natgillin/translations-raw huggingface dataset:
4. 2 og 4. 4).
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Svære negle - forandringer er karakteriseret ved hypo - eller hyper- pigmentering og sommetider smerter og onykolyse.
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
10 Der er rapporter om tilfælde af væskeretention såsom perifert ødem og sjældnere pleura- og perikardieekssudat, ascites og vægtøgning.
Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Det perifere ødem starter sædvanligvis i underekstremiteterne og kan blive generaliseret med vægtstigning på 3 kg eller mere.
10 extremities and may become generalised with a weight gain of 3 kg or more.
4. 4).
Fluid retention is cumulative in incidence and severity (see section 4.4).
Overfølsomhedsreaktioner opstod generelt inden for få minutter efter starten af docetaxel infusionen og reaktionerne var ofte milde til moderate.
Hypersensitivity reactions have generally occurred within a few minutes following the start of the infusion of docetaxel and were usually mild to moderate.
De hyppigst rapporterede symptomer var rødme, udslæt med eller uden kløe, trykken for brystet, rygsmerter, dyspnø og lægemiddelinduceret feberreaktion eller kulderystelser.
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
4. 4).
Severe reactions were characterised by hypotension and/ or bronchospasm or generalized rash/ erythema (see section 4.4).
Docetaxel Winthrop 100 mg/ m² enkeltstof:
Docetaxel Winthrop 100 mg/ m² single agent
Systemorganklasser i henhold til MedDRA - databasen Undersøgelser
MedDRA System Organ classes Investigations
Almindelige bivirkninger ≥ 1 til < 10% af patienterne G3/ 4 Forhøjet bilirubin i blodet (< 5%); G3/ 4 forhøjet alkalisk phosphatase i blodet (< 4%); G3/ 4 ASAT forhøjet (< 3%); G3/ 4 ALAT forhøjet (< 2%)
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients G3/ 4 Blood bilirubin increased (< 5%); G3/ 4 Blood alkaline phosphatase increased (< 4%); G3/ 4 AST increased (< 3%); G3/ 4 ALT increased (< 2%)
Ikke almindelige bivirkninger (≥ 0, 1 til < 1% af patienterne)
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Hjerte Blod og lymfesystem
Cardiac disorders
Neutropeni (G4:
Arrhythmia (G3/ 4:
76, 4%); Anæmi (G3/ 4:
0.7%)
8, 9%); Febril neutropeni
Blood and lymphatic system disorders
Arytmi (G3/ 4:
Neutropenia (G4:
0, 7%) Thrombocytopeni (G4:
Thrombocytopenia (G4:
Hjertesvigt
8.9%); Febrile neutropenia
Perifer sensorisk neuropati (G3:
Peripheral sensory neuropathy (G3:
4, 1%); Perifer motorisk neuropati (G3/ 4:
4.1%); Peripheral motor neuropathy (G3/ 4:
4%) Dysgeusi (alvorlig:
4%); Dysgeusia (severe:
0, 07%)
0.07%)
2, 7%)
2.7%)
5, 3%); Diarré (G3/ 4:
Constipation (severe:
4%); Kvalme (G3/ 4:
5.3%); 0.2%); Diarrhoea (G3/ 4:
3%)
4%); Abdominal pain Nausea (G3/ 4:
Konstipation (alvorlig:
4%); (severe:
1%); Gastrointestinal hæmorrhage (alvorlig:
1%); Vomiting (G3/ 4:
Alopeci; Hudlidelser (G3/ 4:
Alopecia; Skin reaction (G3/ 4:
5, 9%); Neglesygdomme (alvorlig:
5.9%); Nail disorders (severe:
2, 6%)
2.6%)
Myalgi (alvorlig:
Myalgia (severe:
Artralgi
1.4%) Arthralgia
Systemorganklasser i henhold til MedDRA - databasen
MedDRA System Organ classes nutrition disorders
Meget almindelige bivirkninger ≥ 10% af patienterne
Very common adverse reactions ≥ 10% of patients
Almindelige bivirkninger ≥ 1 til < 10% af patienterne
Common adverse reactions ≥ 1 to < 10% of patients
G4- neutropeni (G3/ 4:
Infections (G3/ 4:
Hypotension; Hypertension; Hæmorrhage
Hypotension; Hypertension; Haemorrhage
Væskeretention (alvorlig:
Fluid retention (severe:
11, 2%); smerter
Infusion site reaction; 6.5%); Non-cardiac chest pain Asthenia (severe:
Reaktioner på infusionsstedet; Ikke- kardiale bryst - smerter (alvorlig:
(severe:
Hypersensitivitet (G3/ 4:
Hypersensitivity (G3/ 4:
Blødningsepisoder associeret med grad 3/ 4 thrombocytopeni.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/ 4 thrombocytopenia.
Reversibilitets- data tilgængelige hos 35, 3% af de patienter, som udviklede neurotoksicitet efter docetaxel- behandling med 100 mg/ m2 som enkelt stof.
Nervous system disorders Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/ m² as single agent.
Et enkelt tilfælde af ikke- reversibel alopeci ved slutningen af studiet.
Skin and subcutaneous tissue disorders Very rare: one case of alopecia non-reversible at the end of the study.
Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/ m2 og median- tiden til reversibilitet af væskeretention var 16, 4 uger (range 0 til 42 uger).
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/ m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Begyndelsen af moderat og alvorlig retention var forsinket hos patienter (median kumulativ dosis:
The onset of moderate and severe retention is delayed (median cumulative dose:
489, 7 mg/ m2).
818.9 mg/ m2) in patients with premedication compared with patients without premedication (median cumulative dose:
Det har imidlertid været rapporteret hos nogle patienter under de tidlige kure af behandlingen.
489.7 mg/ m2); however, it has been reported in some patients during the early courses of therapy.
12 Docetaxel Winthrop 75 mg/ m² enkeltstof:
12 Docetaxel Winthrop 75 mg/ m² single agent
Systemorganklasser i henhold til MedDRA- databasen
MedDRA System Organ classes
G3/ 4 Forhøjet bilirubin i blodet (< 2%)
G3/ 4 Blood bilirubin increased (< 2%)
54, 2%); Anæmi (G3/ 4:
54.2%); Anaemia (G3/ 4:
10, 8%); Thrombocytopeni (G4:
10.8%); Thrombocytopenia (G4:
Perifer sensorisk neuropati (G3/ 4:
Peripheral sensory neuropathy (G3/ 4:
Perifer motorisk neuropati (G3/ 4:
Peripheral motor neuropathy (G3/ 4:
Kvalme (G3/ 4:
Nausea (G3/ 4:
1, 7%); Opkastning (G3/ 4:
1.7%); Vomiting (G3/ 4:
0, 8%); Diarré (G3/ 4:
0.8%); Diarrhea (G3/ 4:
Hud og subkutane væv Knogler, led, muskler og bindevæv
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Alopeci; Hudreaktioner (G3/ 4:
Alopecia; Skin reaction (G3/ 4:
Neglesygdomme (alvorlig:
Nail disorders (severe:
0, 8%) Myalgi
0.8%) Myalgia
Metabolisme og ernæring Infektioner og parasitære sygdomme
Metabolism and nutrition disorders
5%)
Anorexia
Vaskulære sygdomme Almene symptomer og reaktioner på administrationsstedet
Infections and infestations Vascular disorders General disorders and administration site conditions
Asteni (alvorlig:
5%) Asthenia (severe:
12, 4%); Væskeretention (alvorlig:
12.4%); Fluid retention (severe:
0, 8%); Smerter
0.8%); Pain
Hypersensitivitet( ikke alvorlig)
Hypersensitivity (no severe)
13 Docetaxel Winthrop 75 mg/ m² i kombination med doxorubicin:
13 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin
Systemorganklasser i henhold til MedDRA - databasen
MedDRA System Organ classes
Meget almindelige bivirkninger ≥ 10% af patienterne
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients
Almindelige bivirkninger ≥ 1 til < 10% af patienterne
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
G3/ 4 Forhøjet bilirubin i blodet (< 2, 5%); G3/ 4 Forhøjet alkalisk phosphatase i blodet (< 2, 5%)
G3/ 4 Blood bilirubin increased (< 2.5%); G3/ 4 Blood alkaline phosphatase increased (< 2.5%)
G3/ 4 ASAT forhøjet (< 1%); G3/ 4 ALAT forhøjet (< 1%)
G3/ 4 AST increased (< 1%); G3/ 4 ALT increased (< 1%)
91, 7%); Anæmi (G3/ 4:
91.7%); Anaemia (G3/ 4:
9, 4%); Febril neutropeni; Thrombocytopeni (G4:
9.4%); Febrile neutropenia; Thrombocytopenia (G4:
Nervesystemet Mave- tarmkanalen
Nervous system disorders
Perifer sensorisk neuropati (G3:
Peripheral sensory Peripheral motor neuropathy (G3:
0, 4%) Kvalme (G3/ 4:
0.4%) neuropathy (G3/ 4:
5%); Stomatitis (G3/ 4:
0.4%)
7, 8%); Diarré (G3/ 4:
Nausea (G3/ 4:
6, 2%); Opkastning (G3/ 4:
5%); Stomatitis (G3/ 4:
5%); Konstipation
7.8%); Diarrhoea (G3/ 4:
Perifer motorisk neuropati (G3/ 4:
6.2%); Vomiting (G3/ 4:
0, 4%)
5%); Constipation
Alopeci; Neglesygdomme (alvorlig 0, 4%); Hudreaktioner (ikke alvorlig)
0.4%); Skin reaction (no severe)
Infektioner og parasitære sygdomme Vaskulære sygdomme
Infections and infestations
Infektioner (G3/ 4:
Infection (G3/ 4:
Almene symptomer og reaktioner på administrationsstedet
Vascular disorders General disorders and administration site conditions
Asteni (alvorlig:
Asthenia (severe:
8, 1 Væskeretention (alvorlig 1, 2%); Smerter
Infusion site reaction 8.1%); Fluid retention (severe:
%); Reaktioner på infusionstedet
Hypotension
14 Docetaxel Winthrop 75 mg/ m2 i kombination med cisplatin:
14 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin
Ikke almindelige bivirkninger ≥ 0, 1 til < 1% af patienterne
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
G3/ 4 Forhøjet bilirubin i blodet (2, 1%); G3/ 4 ALAT forhøjet (1, 3%)
G3/ 4 Blood bilirubin increased (2.1%); G3/ 4 ALT increased (1.3%)
G3/ 4 ASAT forhøjet (0, 5%); G3/ 4 Forhøjet alkalisk phosphatase i blodet (0, 3%)
G3/ 4 AST increased (0.5%); G3/ 4 Blood alkaline phosphatase increased (0.3%)
51, 5%); Anæmi (G3/ 4:
0.7%)
6, 9%); Thrombocytopeni (G4:
Neutropenia (G4:
0, 7%) Febril neutropeni
Febrile neutropenia
Hjertesvigt
Anaemia (G3/ 4:
Nervesystemet
0.5%) Nervous system disorders
3, 7%); Perifer motorisk neuropati (G3/ 4:
3.7%); Peripheral motor neuropathy (G3/ 4:
9, 6%); Konstipation Opkastning (G3/ 4:
9.6%); Vomiting (G3/ 4:
7, 6%); Diarré (G3/ 4:
7.6%); Diarrhoea (G3/ 4:
Alopeci; Neglesygdomme (alvorlig 0, 7%); Hudreaktioner (G3/ 4:
0.7%); Skin reaction (G3/ 4:
Myalgi (alvorlig 0, 5%)
0.5%)
Infektioner (G3/ 4:
5.7%)
5, 7%) Hypotension (G3/ 4:
Hypotension (G3/ 4:
Asteni (alvorlig 9, 9%); Reaktiner på Væskeretention infusionsstedet; (alvorlig 0, 7%); Smerter Feber (G3/ 4:
0.7%); Fever (G3/ 4:
15 Docetaxel Winthrop 100 mg/ m² i kombination med trastuzumab:
15 Docetaxel Winthrop 100 mg/ m² in combination with trastuzumab
Hjerte Blod og lymfesystem
Investigations Cardiac disorders Blood and lymphatic system disorders
Neutropeni (G3/ 4:
Weight increased Neutropenia (G3/ 4:
32%); Febril neutropeni (inclusive neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis
32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø; hoste; næseflåd
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea; Cough; Rhinorrhoea
Alopeci; erythema; udslæt; neglesygdomme
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders
Myalgi; artralgi; smerter i ekstremiteterne; knoglesmerter; rygsmerter
Alopecia; Erythema; Rash; Nail disorders Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain Anorexia
Metabolisme og ernæring Vaskulære sygdomme
Vascular disorders
Anoreksi Lymfødem
Lymphoedema
Symptomatisk hjertesvigt blev rapporteret hos 2, 2% af patienterne, som modtog docetaxel plus trastuzumab i forhold til 0% af de patienter, som fik docetaxel alene.
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
I docetaxel - plus trastuzumab - armen, havde 64% modtaget en tidligere behandling med antracyclin som adjuverende behandling sammenlignet med 55% i docetaxel- armen alene.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Meget almindelig:
Blood and lymphatic system disorders Very common:
Hæmatologisk toksicitet var forhøjet hos de patienter, som modtog trastuzumab og docetaxel, i forhold til de patienter som fik behandling med docetaxel alene (32% grad 3/ 4 neutropeni versus 22%, under anvendelse af NCI- CTC kriterierne).
Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/ 4 neutropenia versus 22%, using NCI-CTC criteria).
Bemærk, at dette sandsynligvis er underestimeret, da docetaxel alene ved en dosis på 100 mg/ m2 er kendt for at resultere i neutropeni hos 97% af patienterne, 76% grad 4, baseret på laveste blodtælling.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/ m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Forekomsten af febril neutropeni/ neutropenisk sepsis var også forhøjet hos de patienter, der fik behandling med Herceptin plus docetaxel (23% versus 17% for de patienter, der fik behandling med docetaxel alene).
The incidence of febrile neutropenia/ neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
16 Docetaxel Winthrop 75 mg/ m² i kombination med capecitabin:
16 Docetaxel Winthrop 75 mg/ m² in combination with capecitabine
Vægttab; G3/ 4 Forhøjet bilirubin i blodet (9%)
Weight decreased; G3/ 4 Blood bilirubin increased (9%)
Neutropeni (G3/ 4:
Neutropenia (G3/ 4:
63%); Anæmi (G3/ 4:
63%); Anaemia (G3/ 4:
Thrombocytopeni (G3/ 4:
Thrombocytopenia (G3/ 4:
Dysgeusi (G3/ 4: < 1%); Paræsthesi (G3/ 4: < 1%)
Dysgeusia (G3/ 4: < 1%); Paraesthesia (G3/ 4: < 1%)
Svimmelhed; Hovedpine (G3/ 4: < 1%); Perifer neuropati
Dizziness; Headache (G3/ 4: < 1%); Neuropathy peripheral
Pharyngolaryngeale smerter (G3/ 4:
Pharyngolaryngeal pain (G3/ 4:
Dyspnø (G3/ 4:
Dyspnoea (G3/ 4:
1%); Hoste (G3/ 4: < 1%); Epistaxis (G3/ 4: < 1%)
1%); Cough (G3/ 4: < 1%); Epistaxis (G3/ 4: < 1%)
18%); Diarré (G3/ 4:
18%); Diarrhoea (G3/ 4:
14%); Kvalme (G3/ 4:
14%); Nausea (G3/ 4:
6%); Opkastning (G3/ 4:
6%); Vomiting (G3/ 4:
4%); Konstipation (G3/ 4:
4%); Constipation (G3/ 4:
1%); Mavesmerter (G3/ 4:
1%); Abdominal pain (G3/ 4:
2%); Dyspepsi
2%); Dyspepsia
Hånd - og fodsyndrom (G3/ 4:
Hand-foot syndrome (G3/ 4:
24%) Alopeci (G3/ 4:
24%); Alopecia (G3/ 4:
6%); Neglesygdomme (G3/ 4:
6%); Nail disorders (G3/ 4:
Dermatitis; Erythematøst udslæt (G3/ 4: < 1%); Misfarvning af negle; Onycholysis (G3/ 4:
Dermatitis; Rash erythematous (G3/ 4: < 1%); Nail discolouration; Onycholysis (G3/ 4:
Knogler, led, muskler og bindevæv
Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders Infections and infestations
Myalgi (G3/ 4:
Myalgia (G3/ 4:
2%); Artralgi (G3/ 4:
2%); Arthralgia (G3/ 4:
1%)
1%) Anorexia (G3/ 4:
1%);
1%); Decreased appetite
1%); Nedsat appetit
Pain in extremity (G3/ 4: < 1%); Back pain (G3/ 4:
2%);
1%) Dehydration (G3/ 4:
Oral candidiasis (G3/ 4: < 1%)
2%) Oral candidiasis (G3/ 4: < 1%)
Asteni (G3/ 4:
Asthenia (G3/ 4:
3%); Pyrexi (G3/ 4:
3%); Pyrexia (G3/ 4:
1%); Træthed/ svaghed (G3/ 4:
1%); Fatigue/ weakness (G3/ 4:
5%); Perifert ødem (G3/ 4:
5%); Oedema peripheral (G3/ 4:
Lethargi; smerter
Lethargy; Pain
17 Docetaxel Winthrop 75 mg/ m² i kombination med prednison eller prednisolon:
17 Docetaxel Winthrop 75 mg/ m² in combination with prednisone or prednisolone
Fald i den kardiale venstre ventrikelfunktion (G3/ 4:
Cardiac left ventricular function decrease (G3/ 4:
32%); Anæmi (G3/ 4:
32%); Anaemia (G3/ 4:
Thrombocytopeni; (G3/ 4:
Thrombocytopenia (G3/ 4:
0, 6%); Febril neutropeni
0.6%); Febrile neutropenia
1, 2%); Dysgeusi (G3/ 4:
1.2%); Dysgeusia (G3/ 4:
Forhøjet lakrimation (G3/ 4:
Lacrimation increased (G3/ 4:
Epistaxis (G3/ 4:
Epistaxis (G3/ 4:
0%); Dyspnø (G3/ 4:
0%); Dyspnoea (G3/ 4:
0, 6%); Hoste (G3/ 4:
0.6%); Cough (G3/ 4:
2, 4%); Diarré (G3/ 4:
2.4%); Diarrhoea (G3/ 4:
0, 9%); Opkastning (G3/ 4:
0.9%); Vomiting (G3/ 4:
Alopeci; Neglesygdomme (ikke alvorlig)
Skin and subcutaneous tissue disorders Musculoskeletal and connective bone disorders Metabolism and nutrition disorders
Exfoliativt udslæt (G3/ 4:
Alopecia; Nail disorders (no severe) Anorexia (G3/ 4:
3, 3%)
Exfoliative rash (G3/ 4:
Artralgi (G3/ 4:
0.3%) Arthralgia (G3/ 4:
0, 3%); Myalgi (G3/ 4:
0.3%); Myalgia (G3/ 4:
Almene symptomer og reaktioner på administrationsstedet
Infections and infestations General disorders and administration site conditions Immune system disorders
Træthed (G3/ 4:
Infection (G3/ 4:
3, 9%); Væskeretention (alvorlig:
3.9%); Fluid retention (severe:
18 Docetaxel Winthrop 75 mg/ m² i kombination med doxorubicin og cyclophosphamid:
18 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin and cyclophosphamide
Meget almindelige bivirkninger ≥ 10% af patienterne Vægtforøgelse eller vægttab (G3/ 4:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased or decreased (G3/ 4:
Ikke almindelige bivirkninger ≥ 0, 1 til < 1% af patienterne
0.1%); Congestive heart failure
Hjerte Blod og lymfesystem
Blood and lymphatic system disorders
Anæmi (G3/ 4:
Anaemia (G3/ 4:
4, 3%); Neutropeni (G3/ 4:
4.3%); Neutropenia (G3/ 4:
65, 5%); Thrombocytopeni (G3/ 4:
65.5%); Thrombocytopenia (G3/ 4:
2, 0%); Febril neuropeni
2.0%); Febrile neutropenia
Dysgeusi (G3/ 4:
Dysgeusia (G3/ 4:
0, 7%); Perifer sensorisk neuropati (G3/ 4:
Peripheral motor 0.7%); neuropathy (G3/ 4:
0%); Neurokortical (G3/ 4:
0%) 0.3%); Neurocerebellar (G3/ 4:
Synkope (G3/ 4:
Syncope (G3/ 4:
Lakrimationsforstyrrels er (G3/ 4:
Lacrimation disorder (G3/ 4:
0, 1%); Konjunktivitis (G3/ 4:
0.1%); Conjunctivitis (G3/ 4:
Hoste (G3/ 4:
Cough (G3/ 4:
5, 1%); Mavesmerter (G3/ 4:
5.1%); Abdominal pain (G3/ 4:
0, 5%) 7, 1%); Opkastning (G3/ 4:
0.5%) 7.1%); Vomiting (G3/ 4:
4, 3%); Diarré (G3/ 4:
4.3%); Diarrhoea (G3/ 4:
3, 2%); Konstipation (G3/ 4:
3.2%); Constipation (G3/ 4:
Colitis/ enteritis / stor intestin perforation
Colitis/ enteritis/ large intestine perforation
Alopeci; Hud toksicitet (G3/ 4:
Alopecia; Skin toxicity (G3/ 4:
0, 7%); Neglesygdomme (G3/ 4:
0.7%); Nail disorders (G3/ 4:
Knogler, led, muskler og bindevæv Metabolisme og ernæring
Musculoskeletal and connective tissue disorders
0, 8%); Artralgi (G3/ 4:
0.8%); Arthralgia (G3/ 4:
0, 4%) Anoreksi (G3/ 4:
Anorexia (G3/ 4:
3, 2%); Neutropenisk infektion.
3.2%); Neutropenic infection.
Der var ingen septiske dødsfald
There were no septic deaths.
Vasodilatation (G3/ 4:
Vasodilatation (G3/ 4:
Hypotension (G3/ 4:
Hypotension (G3/ 4:
Flebitis (G3/ 4:
Phlebitis (G3/ 4:
0%); Lymfødem (G3/ 4:
0%); Lymphoedema (G3/ 4:
Almene symptomer og reaktioner på administrationsstedet
19 MedDRA System Organ classes General disorders and administration site conditions
Asteni (G3/ 4:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Asthenia (G3/ 4:
11%); Feber (G3/ 4:
11%); Fever (G3/ 4:
1, 2%); Periferalt ødem (G3/ 4:
1.2%); Oedema peripheral (G3/ 4:
1, 1%)
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Ikke almindelige bivirkninger ≥ 0, 1 til < 1% af patienterne
Immune system disorders Reproductive system and breast disorders
Det reproduktive system og mammae
Hypersensitivity (G3/ 4:
Amenorré
1.1%) Amenorrhoea
Kongestivt hjertesvigt (CHF) (2, 3% ved 70 måneders median- opfølgning) er også rapporteret.
Congestive Heart Failure (CHF) (2.3% at 70 months median follow-up) has also been reported.
1 patient i hver behandlingsarm døde af hjertesvigt.
One patient in each treatment arm died due to cardiac failure.
Periferal sensorisk neuropati blev set fortsætte ved median- opfølgning på 55 måneder hos 9 patienter ud af 73 patienter med periferal sensorisk neuropati ved slutningen af kemoterapien.
Nervous system disorders Peripheral sensory neuropathy was observed to be ongoing at the median follow-up time of 55 months in 9 patients out of the 73 patients with peripheral sensory neuropathy at the end of the chemotherapy.
Alopeci blev set fortsætte ved median- opfølgning på 55 måneder hos 22 patienter ud af de 687 patienter med alopeci ved slutningen af kemoterapien.
Skin and subcutaneous tissue disorders Alopecia was observed to be ongoing at the median follow-up time of 55 months in 22 patients out of the 687 patients with alopecia at the end of the chemotherapy.
Perifert ødem blev set fortsætte ved median- opfølgning på 55 måneder hos 18 patienter ud af de 112 patienter med perifert ødem ved slutningen af kemoterapien.
General disorders and administration site conditions Oedema peripheral was observed to be ongoing at the median follow-up time of 55 months in 18 patients out of the 112 patients with oedema peripheral at the end of the chemotherapy.
Amenorré blev set fortsætte ved median- opfølgning på 55 måneder hos 133 patienter ud af de 233 patienter med amenorré ved slutningen af kemoterapien.
Reproductive system and breast disorders Amenorrhoea was observed to be ongoing at the median follow-up time of 55 months in 133 patients out of the 233 patients with amenorrhoea at the end of the chemotherapy.
20 Docetaxel Winthrop 75 mg/ m² i kombination med cisplatin og 5- fluorouracil til gastrisk adenocarcinoma- kræft:
20 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
Systemorganklasser i henhold til MedDRA- databasen Hjerte Blod og lymfesystem
MedDRA System Organ classes
Meget almindelige bivirkninger Almindelige bivirkninger ≥ 10% af patienterne ≥ 1 til < 10% af patienterne Arytmi (G3/ 4:
Common adverse reactions ≥ 1 to < 10% of patients
1, 0%) Anæmi (G3/ 4:
Anaemia (G3/ 4:
20, 9%); Neutropeni (G3/ 4:
20.9%); Neutropenia (G3/ 4:
83, 2%); Thrombocytopeni (G3/ 4:
83.2%); Thrombocytopenia (G3/ 4:
8, 8%); Febril neutropeni
8.8%); Febrile neutropenia
Perifer sensorisk neuropati (G3/ 4:
8.7%)
Svimmelhed (G3/ 4:
Dizziness (G3/ 4:
2, 3%); 8, 7%) Perifer motorisk neuropati (G3/ 4:
2.3%); Peripheral motor neuropathy (G3/ 4:
Øre og labyrint Mave- tarmkanalen
Ear and labyrinth disorders
Nedsat hørelse (G3/ 4:
Hearing impaired (G3/ 4:
0%) Diarré (G3/ 4:
0%)
19, 7%); Konstipation (G3/ 4:
Diarrhoea (G3/ 4:
1, 0%); Kvalme (G3/ 4:
19.7%); Nausea (G3/ 4:
16%); Gastrointestinale smerter (G3/ 4:
14.3%)
Stomatitis (G3/ 4:
Constipation (G3/ 4:
23, 7%); 1, 0%); Opkastning (G3/ 4:
1.0%); Gastrointestinal pain (G3/ 4:
14, 3%) Oesophagitis/ dysfagi/ odynofagi (G3/ 4:
1.0%); Oesophagitis/ dysphagia/ odynop hagia (G3/ 4:
Alopeci (G3/ 4:
Alopecia (G3/ 4:
4, 0%) Kløende udslæt (G3/ 4:
Rash pruritus (G3/ 4:
0, 7%); Hudafskalning (G3/ 4:
0.7%); Skin exfoliation (G3/ 4:
Anoreksi (G3/ 4:
Anorexia (G3/ 4:
Neutropenisk infektion; Infektion (G3/ 4:
Neutropenic infection; Infection (G3/ 4:
Lethargi (G3/ 4:
Lethargy (G3/ 4:
19, 0%); Feber (G3/ 4:
19.0%); Fever (G3/ 4:
2, 3%); Væskeretention (alvorlig/ livstruende:
2.3%); Fluid retention (severe/ life- threatening:
Febril neutropeni og neutropenisk infektion forekom hos respektivt 17, 2% og 13, 5% af patienterne, uanset anvendelse af G- CSF.
Blood and lymphatic system disorders Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
G- CSF blev anvendt som sekundær profylakse hos 19, 3% af patienterne (10, 7% af cyklus).
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Febril neutropeni og neutropenisk infektion forekom respektivt hos 12, 1% og 3, 4% af patienterne, når patienterne modtog profylaktisk G- CSF, hos 15, 6% og 12, 9% af patienterne uden profylaktisk G- CSF (se punkt 4. 2).
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
21 Docetaxel Winthrop 75 mg/ m² i kombination med cisplatin og 5- fluorouracil (til hoved - og halskræft):
21 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
• Induktions kemoterapi efterfulgt af strålebehandling (TAX 323)
• Induction chemotherapy followed by radiotherapy (TAX 323)
Systemorganklasser i henhold til MedDRA - databasen Undersøgelser
MedDRA System Organ classes
Meget almindelige bivirkninger ≥ 10% af patienterne
Common adverse reactions ≥ 1 to < 10% of patients