natgillin/translations-raw huggingface dataset:
Свързани с лечението нежелани реакции, съобщени при GIST- проучвания
Treatment-Related Adverse Reactions reported in GIST studies
Системо - органнен клас
System Organ Class
Много чести Много чести Много чести
Very common Very common Very common Common Common
Анемия Неутропения Тромбоцитопения
Anaemia Neutropoenia Thrombocytopoenia Leukopoenia Lymphopoenia
86 (19, 5%) 81 (18, 4%) 67 (15, 2%)
86 (19.5%) 81 (18.4%) 67 (15.2%) 26 (5.9%) 10 (2.3%)
24 (5, 5%) 39 (8, 9%) 19 (4, 3%)
24 (5.5%) 39 (8.9%) 19 (4.3%) 9 (2.0%) 3 (0.7%)
3 (0, 7%) 5 (1, 1%) 6 (1, 4%)
3 (0.7%) 5 (1.1%) 6 (1.4%) 1 (0.2%) 1 (0.2%)
Чести Чести
Endocrine disorders
9 (2, 0%) 3 (0, 7%)
Very common
1 (0, 2%) 1 (0, 2%)
Hypothyroidism
59 (13, 4%)
59 (13.4%)
5 (1, 1%)
5 (1.1%)
1 (0, 2%)
1 (0.2%)
Намален апетит a
Decreased appetite a
117 (26, 6%)
117 (26.6%)
8 (1, 8%)
8 (1.8%)
0 (0, 0%)
0 (0.0%)
Нарушение на вкуса b
Taste disturbance b
105 (23, 9%)
105 (23.9%)
Много чести Чести Чести Чести
System Organ Class
Главоболие Парестезии Замайване Периферна невропатия
Adverse Reactions
76 (17, 3%) 27 (6, 1%) 18 (4, 1%) 11 (2, 5%)
All Grades n (%)
5 (1, 1%) 1 (0, 2%) 1 (0, 2%) 0 (0, 0%)
Grade 3 n (%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
Grade 4 n (%)
Чести
Very common Common Common Common Common
Хипоестезия
Headache Paraesthesia Dizziness Neuropathy peripheral Hypoaesthesia
10 (2, 3%)
76 (17.3%) 27 (6.1%) 18 (4.1%) 11 (2.5%) 10 (2.3%)
0 (0, 0%)
5 (1.1%) 1 (0.2%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
101 (23, 0%)
101 (23.0%)
43 (9, 8%)
43 (9.8%)
Епистаксис
Epistaxis Dyspnoea
28 (6, 4%)
28 (6.4%) 16 (3.6%)
1 (0, 2%)
1 (0.2%) 2 (0.5%)
0 (0, 0%)
0 (0.0%) 0 (0.0%)
Диспнея
Renal and urinary disorders
18 (4, 1%)
18 (4.1%)
Много чести Много чести Много чести Много чести Много чести
Very common Very common Very common Very common Very common Very common
Гадене Повръщане Стоматит Диспепсия Болка в корема с / подуване
Diarrhoea Nausea Vomiting Stomatitis Dyspepsia Abdominal pain C / distension
161 (36, 6%) 98 (22, 2%) 90 (20, 5%) 80 (18, 2%) 77 (17, 5%)
187 (42.5%) 161 (36.6%) 98 (22.2%) 90 (20.5%) 80 (18.2%) 77 (17.5%)
15 (3, 4%) 7 (1, 6%) 7 (1, 6%) 4 (0, 9%) 15 (3, 4%)
24 (5.5%) 15 (3.4%) 7 (1.6%) 7 (1.6%) 4 (0.9%) 15 (3.4%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 2 (0, 5%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (0.5%)
Много чести Много чести Чести Чести Чести Чести
Very common Very common Common Common Common Common
Метеоризъм Болка в устата Запек Глосодиния Сухота в устата Гастроезофагеална рефлуксна болест
Flatulence Oral pain Constipation Glossodynia Dry mouth Gastro-oesophageal reflux disease
46 (10, 5%) 44 (10, 0%) 37 (8, 4%) 37 (8, 4%) 31 (7, 0%) 12 (2, 7%)
46 (10.5%) 44 (10.0%) 37 (8.4%) 37 (8.4%) 31 (7.0%) 12 (2.7%)
0 (0, 0%) 2 (0, 5%) 2 (0, 5%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%)
0 (0.0%) 2 (0.5%) 2 (0.5%) 0 (0.0%) 0 (0.0%) 1 (0.2%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Разязвяване на устата
Mouth ulceration Oral discomfort
11 (2, 5%)
11 (2.5%) 11 (2.5%)
Орален дискомфорт
Skin and subcutaneous
11 (2, 5%)
Very common
Нарушения на кожата и подкожната тъкан
Yellow skin/ Skin discolouration
146 (33, 2%)
146 (33.2%)
Много чести
tissue disorders
Синдром на палмаро - плантарна еритродизестезия
Palmar-plantar erythrodysaesthesia syndrome
106 (24, 1%)
106 (24.1%)
27 (6, 1%)
27 (6.1%)
Много чести Чести Чести Чести Чести Чести Чести Чести Чести Чести
Very common Very common Common Common Common Common Common Common Common Common Common
Обрив Суха кожа Алопеция Дерматит Периорбитален оток Кожна реакция Еритем Екзема Пруритус Хиперпигментация на кожата
Hair colour changes Rash Dry skin Alopecia Dermatitis Periorbital oedema Skin Reaction Erythema Eczema Pruritus Skin hyperpigmentation
64 (14, 5%) 41 (9, 3%) 33 (7, 5%) 29 (6, 6%) 20 (4, 5%) 20 (4, 5%) 18 (4, 1%) 16 (3, 6%) 16 (3, 6%) 15 (3, 4%)
67 (15.2%) 64 (14.5%) 41 (9.3%) 33 (7.5%) 29 (6.6%) 20 (4.5%) 20 (4.5%) 18 (4.1%) 16 (3.6%) 16 (3.6%) 15 (3.4%)
3 (0, 7%) 0 (0, 0%) 0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 3 (0, 7%) 0 (0, 0%) 1 (0, 2%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 3 (0.7%) 0 (0.0%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 3 (0.7%) 0 (0.0%) 1 (0.2%) 0 (0.0%) 0 (0.0%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Лющене на кожата Мехури Кожна лезия
Skin exfoliation Blister Skin lesion
12 (2, 7%) 10 (2, 3%) 10 (2, 3%)
12 (2.7%) 10 (2.3%) 10 (2.3%)
0 (0, 0%) 1 (0, 2%) 1 (0, 2%)
0 (0.0%) 1 (0.2%) 1 (0.2%)
0 (0, 0%) 0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%)
Нарушения на мускулно -
Muscoloskeletal, connective tissue
Болки в крайници/ крайник
Pain in extremity/ limb Arthralgia
54 (12, 3%)
54 (12.3%) 39 (8.9%)
5 (1, 1%)
5 (1.1%) 3 (0.7%)
скелетната система, съединителната тъкан и костите
9
10 Системо - органнен клас
System Organ Class
Много чести
and bone disorders
Много чести Чести
Common Common Common Common
Оток d Пирексия
Myalgia Muscle spasm Back pain Muscular weakness
59 (13, 4%) 26 (5, 9%)
29 (6.6%) 21 (4.8%) 11 (2.5%) 10 (2.3%)
1 (0, 2%) 2 (0, 5%)
0 (0.0%) 1 (0.2%) 2 (0.5%) 1 (0.2%)
0 (0, 0%) 0 (0, 0%)
0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Психични нарушения
General disorders and administration site conditions Psychiatric disorders
Чести
Very common Very common Very common Common Common
Безсъние
Fatigue/ Asthenia Mucosal inflammation Oedema d Pyrexia Insomnia
14 (3, 2%)
287 (65.2%) 70 (15.9%) 59 (13.4%) 26 (5.9%) 14 (3.2%)
0 (0, 0%)
64 (14.5%) 6 (1.4%) 1 (0.2%) 2 (0.5%) 0 (0.0%)
0 (0, 0%)
5 (1.1%) 1 (0.2%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Повишена липаза Намален брой на белите кръвни клеткие
Lipase increase White blood cell count decreased e
35 (8, 0%) 33 (7, 5%)
35 (8.0%) 33 (7.5%)
12 (2, 7%) 15 (3, 4%)
12 (2.7%) 15 (3.4%)
7 (1, 6%) 0 (0, 0%)
7 (1.6%) 0 (0.0%)
5 (1, 2%)
5 (1.2%)
Понижен хемоглобин 27 (6, 1%) Повишена креатинин 22 (5, 0%) фосфокиназа в кръвта
27 (6.1%)
6 (1, 4%) 1 (0, 2%)
6 (1.4%)
0 (0, 0%) 1 (0, 2%)
0 (0.0%)
Намален брой на 25 (5, 7%) тромбоцитите
Platelet count decrease
4 (0, 9%)
4 (0.9%)
Намаляване на 23 (5, 2%) телесното тегло
23 (5.2%) 22 (5.0%)
1 (0, 2%)
1 (0.2%) 1 (0.2%)
0 (0, 0%)
0 (0.0%) 1 (0.2%)
Повишена амилаза 21 (4, 8%) Повишена аспартат 18 (4, 1%) аминотрансфераза
Amylase increased Aspartate aminotransferase increased
8 (1, 8%) 2 (0, 5%)
21 (4.8%) 18 (4.1%)
0 (0, 0%) 1 (0, 2%)
0 (0.0%) 1 (0.2%)
Повишена аланин 12 (2, 7%) аминотрансфераза
Alanine aminotransferase increased
Някакво нежелано събитие
Any adverse event
414 (94, 1%)
414 (94.1%)
204 (46, 4%) 53 (12, 0%)
204 (46.4%)
* Следните термини са били комбинирани: a Анорексия и намален апетит b Променен вкус, липса на вкус и нарушения на вкуса c Болка в корема и болка в епигастриума d Оток, периферен оток и оток на лицето е Намален брой на белите кръвни клетки, намален брой на неутрофилите и намален брой на левкоцитите
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Свързани с лечението нежелани реакции, съобщени от проучвания за цитокин - рефрактерен и нелекуван до момента MRCC
Treatment-Related Adverse Reactions reported in cytokine-refractory and treatment-naïve MRCC studies
Много чести Много чести Много чести
Very common Very common
Неутропения Тромбоцитопения Анемия
Neutropoenia Thrombocytopoenia
89 (16, 4%) 86 (15, 8%) 67 (12, 3%)
89 (16.4%) 86 (15.8%)
46 (8, 5%) 37 (6, 8%) 20 (3, 7%)
46 (8.5%) 37 (6.8%)
5 (0, 9%) 5 (0, 9%) 3 (0, 6%)
5 (0.9%) 5 (0.9%)
Чести Чести
Very common Common Common
Левкопения Лимфопения
Anaemia Leukopoenia Lymphopenia
45 (8, 3%) 21 (3, 9%)
67 (12.3%) 45 (8.3%) 21 (3.9%)
16 (2, 9%) 12 (2, 2%)
20 (3.7%) 16 (2.9%) 12 (2.2%)
0 (0%) 1 (0, 2%)
3 (0.6%) 0 (0%) 1 (0.2%)
Нарушения на ендокринната система
Endocrine
67 (12, 3%)
67 (12.3%)
7 (1, 3%)
7 (1.3%)
11 Системо - органнен клас
System Organ Class disorders
Увеличено сълзоотделяне
Lacrimation increased
39 (7, 2%)
39 (7.2%)
12 (2, 2%)
12 (2.2%)
Чести
Very Common Common
Намален апетит a
Decreased appetite Dehydration
205 (37, 7%)
205 (37.7%) 33 (6.1%)
9 (1, 7%)
9 (1.7%) 7 (1.3%)
0 (0%)
0 (0%) 1 (0.2%)
Много чести
Very common Very common Common Common Common
Нарушения на вкуса b
Taste disturbance b Headache Dizziness Paraesthesia Neuropathy peripheral
250 (46, 0%)
250 (46.0%) 82 (15.1%) 38 (7.0%) 36 (5.9%) 33 (6.1%)
0 (0%)
1 (0.2%) 3 (0.6%) 2 (0.4%) 0 (0%) 1 (0.2%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Хипоестезия Хиперестезия
Hypoaesthesia Hyperaesthesia
20 (3, 7%) 17 (3, 1%)
20 (3.7%) 17 (3.1%)
Много чести
Very common Common Common
Хипертония
Hypertension Flushing Hot flush
143 (26, 3%)
143 (26.3%) 17 (3.1%) 12 (2.2%)
0 (0%)
55 (10.1%) 0 (0%) 0 (0%)
0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%)
Респираторни, гръдни и медиастиналн и нарушения
Respiratory, thoracic and
86 (15, 8%)
86 (15.8%)
3 (0, 6%)
3 (0.6%)
Диспнея Фаринго - ларингеална болка
Dyspnoea
45 (8, 3%) 29 (5, 3%)
45 (8.3%)
6 (1, 1%) 2 (0, 4%)
6 (1.1%)
Чести Чести Чести Чести
Common
Кашлица Дисфония Сухота в носа Диспнея при усилие
Pharyngolaryngeal pain
23 (4, 2%) 16 (2, 9%) 14 (2, 6%) 12 (2, 2%)
29 (5.3%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
2 (0.4%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%)
Чести Чести
Common Common Common Common Common Common
Назална конгестия Плеврален излив
Cough Dysphonia Nasal dryness Dyspnoea exertional Nasal congestion Pleural effusion
12 (2, 2%) 12 (2, 2%)
23 (4.2%) 16 (2.9%) 14 (2.6%) 12 (2.2%) 12 (2.2%) 12 (2.2%)
0 (0%) 3 (0, 6%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 3 (0.6%)
0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Много чести
Very common Very common Very common Very common Very common Very common
Диария
Diarrhoea Nausea Dyspepsia Stomatitis Vomiting Abdominal pain c / distension
326 (59, 9%)
326 (59.9%) 290 (53.3%) 189 (34.7%) 185 (34.0%) 178 (32.7%) 106 (19.5%)
38 (7, 0%)
38 (7.0%) 19 (3.5%) 8 (1.5%) 13 (2.4%) 17 (3.1%) 10 (1.8%)
0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Много чести Много чести Много чести Много чести Много чести
Very common Very common Very common Very common Very common Common
Гадене Диспепсия Стоматит Повръщане Коремна болка c / подуване
Constipation Glossodynia Flatulence Oral pain Dry mouth Gastroesophageal reflux disease
290 (53, 3%) 189 (34, 7%) 185 (34, 0%) 178 (32, 7%) 106 (19, 5%)
83 (15.3%) 63 (11.6%) 60 (11.0%) 60 (11.0%) 56 (10.3%) 50 (9.2%)
19 (3, 5%) 8 (1, 5%) 13 (2, 4%) 17 (3, 1%) 10 (1, 8%)
1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 0 (0%) 2 (0.4%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Много чести Много чести Много чести Много чести Много чести Чести
Common Common Common Common Common Common Common Common
Запек Глосодиния Метеоризъм Болка в устата Сухота в устата Гастро - езофагеална рефлуксна болест
Dysphagia Cheilitis Gingival bleeding Haemorrhoids Proctalgia Mouth ulceration Stomach discomfort Rectal haemorrhage
83 (15, 3%) 63 (11, 6%) 60 (11, 0%) 60 (11, 0%) 56 (10, 3%) 50 (9, 2%)
20 (3.7%) 19 (3.5%) 18 (3.3%) 18 (3.3%) 17 (3.1%) 16 (2.9%) 15 (2.8%) 13 (2.4%)
1 (0, 2%) 0 (0%) 0 (0%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
1 (0.2%) 1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 1 (0.2%) 0 (0%) 0 (0%)
Стомашен дискомфорт
Skin and subcutaneous tissue disorders
Ректален кръвоизлив
Palmar-plantar erythrodysaesthesia syndrome
144 (26, 5%)
144 (26.5%)
46 (8, 5%)
46 (8.5%)
Пожълтяване на кожата/ Промяна в цвета на кожата
Yellow discolouration/ Skin discolouration
Много чести Много чести Много чести
Very common Very common Very common Very common Common Common Common Common Common Common Common
Обрив Суха кожа Изменения в цвета на косата
Rash Dry skin Hair colour changes Alopecia Erythema Skin exfoliation Pruritus Periorbital oedema Dermatitis Skin lesion Nail disorder/ discolouration
121 (22, 2%) 108 (19, 9%) 103 (18, 9%)
121 (22.2%) 108 (19.9%) 103 (18.9%) 64 (11.8%) 51 (9.4%) 47 (8.6%) 40 (7.4%) 31 (5.7%) 27 (5.0%) 26 (4.8%) 25 (4.6%)
2 (0, 4%) 1 (0, 2%) 0 (0%)
2 (0.4%) 1 (0.2%) 0 (0%) 0 (0%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 1 (0.2%) 4 (0.7%) 1 (0.2%) 0 (0%)
1 (0, 2%) 0 (0%) 0 (0%)
1 (0.2%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Много чести Чести Чести
Common Common Common Common
Алопеция Еритем Лющене на кожата
Blister Skin reaction Hyperkeratosis Acne
64 (11, 8%) 51 (9, 4%) 47 (8, 6%)
23 (4.2%) 23 (4.2%) 22 (4.0%) 19 (3.5%)
0 (0%) 2 (0, 4%) 4 (0, 7%)
1 (0.2%) 6 (1.1%) 4 (0.7%) 0 (0%)
0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%)
Сърбеж Периорбитален оток
Musculoskeletal and connective tissue disorders
Чести Чести Чести
Very common Common Common Common Common
Дерматит Кожна лезия Нарушения на ноктите/ промяна в цвета
Pain in extremity Arthralgia Myalgia Muscle Spasm Back pain
27 (5, 0%) 26 (4, 8%) 25 (4, 6%)
96 (17.6%) 49 (9.0%) 48 (8.8%) 26 (4.8%) 17 (3.1%)
4 (0, 7%) 1 (0, 2%) 0 (0%)
6 (1.1%) 1 (0.2%) 2 (0.4%) 0 (0%) 2 (0.4%)
0 (0%) 0 (0%) 0 (0%)
0 (0%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
Чести Чести Чести Чести
General disorders and administration
23 (4, 2%) 23 (4, 2%) 22 (4, 0%) 19 (3, 5%)
Very common Very common
1 (0, 2%) 6 (1, 1%) 4 (0, 7%) 0 (0%)
Fatigue/ asthenia Mucosal inflammation
0 (0%) 0 (0%) 0 (0%) 0 (0%)
397 (73.0%) 127 (23.3%)
96 (17, 6%)
95 (17.5%) 8 (1.5%)
0 (0%)
1 (0.2%) 0 (0%)
Чести Чести Чести Чести
Very common Common Common Common Common
Артралгия Миалгия Мускулен спазъм Болка в гърба
Oedema d Pyrexia Chills Pain Chest pain
49 (9, 0%) 48 (8, 8%) 26 (4, 8%) 17 (3, 1%)
99 (18.2%) 37 (6.8%) 35 (6.4%) 20 (3.7%) 13 (2.4%)
1 (0, 2%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
5 (0.9%) 3 (0.6%) 2 (0.4%) 0 (0%) 2 (0.4%)
Общи нарушения и ефекти на мястото на приложение
Psychiatric disorders Investigations
Много чести
Common Common Very common
13 Системо - органнен клас
Insomnia Depression Ejection fraction decreased
Всички степени n (%)
22 (4.0%) 15 (2.8%) 84 (15.4%)
Степен 4 n (%)
0 (0%) 1 (0.2%) 16 (2.9%)
0 (0%)
0 (0%) 0 (0%) 0 (0%)
Оток d
Weight decreased Platelet count decreased
99 (18, 2%)
57 (10.5%) 41 (7.5%)
5 (0, 9%)
1 (0.2%) 15 (2.8%)
0 (0%)
0 (0%) 2 (0.4%)
Пирексия Студени тръпки Болка Гръдна болка
White blood cell count decreased e
37 (6, 8%) 35 (6, 4%) 20 (3, 7%) 13 (2, 4%)
37 (6.8%)
3 (0, 6%) 2 (0, 4%) 0 (0%) 2 (0, 4%)
16 (2.9%)
Чести Чести Много чести
Common Common
22 (4, 0%) 15 (2, 8%) 84 (15, 4%)
Lipase increased Haemoglobin decreased
0 (0%) 1 (0, 2%) 16 (2, 9%)
36 (6.6%) 25 (4.6%)
0 (0%) 0 (0%) 0 (0%)
19 (3.5%) 8 (1.5%)
0 (0%)
11 (2%) 0 (0%)
Намален брой на тромбоцитите
Blood creatine phosphokinase increased
41 (7, 5%)
19 (3.5%)
15 (2, 8%)
7 (1.3%)
2 (0, 4%)
2 (0.4%)
Намален брой на белите кръвни клетки е
Aspartate aminotransferase
37 (6, 8%)
18 (3.3%)
16 (2, 9%)
7 (1.3%)
7 (1, 3%)
12
2 (0, 4%)
System Organ Class
Повишена аспартат аминотрансфераза
Adverse Reactions increased
18 (3, 3%)
All Grades n (%)
7 (1, 3%)
Grade 3 n (%)
0 (0%)
Grade 4 n (%)
18 (3, 3%)
18 (3.3%)
11 (2, 0%)
11 (2.0%)
15 (2, 8%)
15 (2.8%)
14 (2, 6%)
14 (2.6%)
524 (96, 3%)
524 (96.3%)
296 (54, 4%)
296 (54.4%)
57 (10, 5%)
57 (10.5%)
Променен вкус, липса на вкус и нарушения на вкуса c Болка в корема и болка в епигастриума d Оток, периферен оток и оток на лицето е Намален брой на белите кръвни клетки, намален брой на неутрофилите и намален брой на левкоцитите
The following terms have been combined: a Anorexia and decreased appetite b Dysgeusia, ageusia and taste disturbance c Abdominal pain and abdominal pain upper d Oedema, oedema peripheral and oedema face e White blood cell count decreased, neutrophil count decreased, and leukocyte count decreased
Нежелани реакции от постмаркетинговия опит
Adverse reactions from post-marketing experience
Следните нежелани реакции се съобщават от постмаркетинговия опит със SUTENT.
The following adverse reactions have been identified during post-approval use of SUTENT.
14 проучвания, разширени програми за достъп, клинично- фармакологични проучвания и изследователски проучвания за неодобрени показания.
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Сърдечна недостатъчност, застойна сърдечна недостатъчност, левокамерна недостатъчност
Cardiac failure, cardiac failure congestive, left ventricular failure Prolonged QT interval, Torsade de pointes
Стомашно- чревни Нечести:
Uncommon:
Хепато- билиарни Нечести:
Pancreatitis Gastrointestinal perforation
Удължен QT интервал, torsade de pointes нарушения:
Hepatobiliary disorders:
Панкреатит Стомашно- чревна перфорация нарушения:
Investigations:
Повишен тироид стимулиращ хормон (TSH)
Elevated thyroid stimulating hormone (TSH)
Инфекции и инфестации:
Infections and Infestations Non known:
С неизвестна честота:
Pulmonary disorders
Инфекции (с или без неутропения)
Infections (with or without neutropoenia) connective tissue disorders Myopathy and/ or rhabdomyolysis
Миопатия и/ или рабдомиолиза
Pleural effusion Pulmonary embolism and respiratory failure
Плеврален излив
Thromboembolic events:
Белодробен емболизъм и дихателна недостатъчност
Cases of pulmonary embolism, in some cases with fatal outcome, have been reported.
Тромбоемболични
Infection and infestations:
събития: съобщавани са случаи на белодробен емболизъм, в някои случаи
Cases of serious infection (with or without neutropoenia), including pneumonia, have been reported.
с фатален изход.
Few cases had a fatal outcome.
Няколко случая са били с фатален изход.
Musculoskeletal and connective tissue disorders:
Нарушения на мускулно- скелетната система и съединителната тъкан: съобщават се редки случаи на миопатия и/ или рабдомиолиза, някои от които с бъбречна недостатъчност.
Rare cases of myopathy and/ or rhabdomyolysis, some with acute renal failure, have been reported.
Нарушения на кръвта и лимфната система: съобщавани са редки случаи на тромботична микроангиопатия.
Rare cases of thrombotic microangiopathy have been reported.
Препоръчва се временно прекъсване на SUTENT; след преминаване на състоянието лечението може да бъде възобновено по преценка на лекуващия лекар.
Temporary suspension of SUTENT is recommended; following resolution, treatment may be resumed at the discretion of the treating physician.
Нарушения на ендокринната система: при клинични изпитвания и през постмаркетинговия опит са съобщавани редки случаи на хипертиреоидизъм, някои от които последвани от хипотиреоидизъм (вж. също точка 4. 4).
Rare cases of hyperthyroidism, some followed by hypothyroidism, have been reported in clinical trials and through post-marketing experience (See also section 4.4).
Нарушения на бъбреците и пикочните пътища: съобщавани са случаи на протеинурия и редки случаи на нефротичен синдром.
Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Безопасността на продължително лечение със SUTENT при пациенти с умерена до тежка протеинурия не е системно оценена.
The safety of continued SUTENT treatment in patients with moderate to severe proteinuria has not been systematically evaluated.
Прекратете лечението със SUTENT при пациенти с нефротичен синдром (вж. също точка 4. 4).
Discontinue SUTENT in patients with nephrotic syndrome (see also section 4.4).
Липсва опит с остро предозиране със SUTENT.
There is no experience of acute overdosage with SUTENT.
Няма специфичен антидот срещу предозиране със SUTENT и лечението на предозирането трябва да се състои от общи подържащи мерки.
There is no specific antidote for overdosage with SUTENT and treatment of overdose should consist of general supportive measures.
Ако е показано, елиминирането на нерезорбираното лекарство може да се постигне чрез повръщане или промиване на стомаха.
If indicated, elimination of unabsorbed drug may be achieved by emesis or gastric lavage.
Антинеопластични средства - Инхибитор на протеин- тирозин киназата; ATC код:
Antineoplastic agents - Protein-tyrosine kinase inhibitor, ATC Code:
LO1XE04.
LO1XE04
Сунитиниб малеат инхибира множество рецепторни тирозин кинази (RTKs), които участват в туморния растеж, патологичната ангиогенеза и метастатичното развитие на рака.
Sunitinib malate inhibits multiple receptor tyrosine kinases (RTKs) that are implicated in tumour growth, pathologic angiogenesis, and metastatic progression of cancer.
Сунитиниб e бил идентифициран като инхибитор на рецепторите на получения от тромбоцити растежен фактор (PDGFRα и PDGFRβ), рецепторите на съдовия ендотелен растежен фактор (VEGFR1, VEGFR2 и VEGFR3), рецептора на фактора на стволовите клетки (KIT), Fms- подобната тирозин киназа 3 (FLT3), рецептора на стимулиращия колонията фактор (CSF- 1R) и рецептора на получения от глиална клетъчна линия невротрофичен фактор (RET).
Sunitinib was identified as inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
Ефикасността се основава на времето до туморна прогресия и увеличаване на преживяемостта при GIST, както и на преживяемост без прогресия и честотата на обективен отговор съответно при нелекуван и цитокин- рефрактерен MRCC.
CLINICAL STUDIES The clinical safety and efficacy of SUTENT has been studied in the treatment of patients with malignant gastrointestinal stromal tumour (GIST) who were resistant to imatinib (i. e. those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i. e. those who experienced significant toxicity during treatment with imatinib that precluded further treatment) and the treatment of patients with metastatic renal cell carcinoma (MRCC) Efficacy is based on time to tumour progression and an increase in survival in GIST and on progression free survival and objective response rates for treatment-naïve and cytokine-refractory MRCC respectively.
Гастро- интестинален стромален тумор Първоначално открито проучване с повишаване на дозата е било проведено при пациенти с GIST след неуспех с иматиниб (средна максимална дневна доза 800 mg) поради резистентност или непоносимост.
Gastrointestinal Stromal Tumours An initial open-label, dose-escalation study was conducted in patients with GIST after failure of imatinib (Median maximum daily dose 800 mg) due to resistance or intolerance.
Включени са били деветдесет и седем пациента при различни дози и схеми; 55 пациента са получавали 50 mg по препоръчваната схема на лечение 4 седмици на/ 2 седмици без (” схема 4/ 2 ”).
Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment schedule 4 weeks on / 2 weeks off (“ schedule 4/ 2”).
В това проучване, средното Време до Прогресия (TTP) е било 34, 0 седмици (95% CI = 22, 0 – 46, 0 седмици).
In this study the median Time To Progression (TTP) was 34.0 weeks (95% CI = 22.0 – 46.0 weeks).
При пациенти с непоносимост към иматиниб, или изпитали прогресия на болестта по време или след лечение с иматиниб (средна максимална дневна доза 800 mg) е било проведено фаза 3 рандомизирано, двойно- сляпо, плацебо- контролирано проучване на SUTENT.
A phase 3, randomized, double-blind, placebo-controlled study of SUTENT was conducted in patients with GIST who were intolerant to, or had experienced disease progression during or following treatment with, imatinib (Median maximum daily dose 800 mg).
В това проучване, 312 пациенти са били рандомизирани (2: 1) да получават перорално веднъж дневно по Схема 4/ 2 50 mg SUTENT или плацебо до прогресия на заболяването или оттегляне от проучването по друга причина (207 пациенти са получавали SUTENT, а 105 пациенти са получавали плацебо).
In this study, 312 patients were randomized (2:1) to receive either 50 mg SUTENT or placebo, orally once daily on Schedule 4/ 2 until disease progression or withdrawal from the study for another reason (207 patients received SUTENT and 105 patients received placebo).