よむ、つかう、まなぶ。
資料5-3 Ⅳ-144、145 フルダラビン［1.7MB］ (24 ページ)
出典
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| 出典情報 | 医療上の必要性の高い未承認薬・適応外薬検討会議（第66回 12／12）《厚生労働省》 |
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要望番号；IV-144
CHC n(%)
CHC n(%)
Reduced granulocytes
164 (86%)
84 (90%)
80 (92%)
Reduced haemoglobin
153 (81%)
75 (79%)
75 (85%)
Reduced leukocytes
170 (89%)
85 (89%)
82 (93%)
Reduced platelets
171 (90%)
91 (95%)
82 (93%)
Haemolysis
2 (1%)
0 (0%)
3 (4%)
Non-Haematologic toxicity
163 (86%)
75 (78%)
75 (84%)
Allergic
1 (1%)
0 (0%)
1 (1%)
1 (1%)
1 (1%)
1 (1%)
0 (0%)
0 (0%)
2 (3%)
1 (1%)
0 (0%)
6 (7%)
Serum sickness
0 (0%)
0 (0%)
0 (0%)
Arrhythmia
3 (2%)
1 (1%)
3 (4%)
Cardiac function
7 (4%)
1 (1%)
2 (3%)
DIC (disseminated
0 (0%)
0 (0%)
1 (1%)
Thrombotic microangiopathy 4 (2%)
0 (0%)
2 (2%)
Acute vascular leak
5 (3%)
3 (3%)
1 (1%)
Thrombosis/embolism
0 (0%)
0 (0%)
0 (0%)
Changes in the skin
4 (2%)
3 (3%)
8 (9%)
Diarrhoea
24 (13%)
14 (15%)
17 (19%)
Vomiting
24 (13%)
7 (7%)
18 (20%)
Stomatitis
124 (65%)
42 (44%)
49 (56%)
Nausea
70 (37%)
27 (28%)
32 (36%)
Colitis
5 (3%)
3 (3%)
3 (4%)
Ileus, gastrointestinal
3 (2%)
2 (2%)
4 (5%)
CNS haemorrhage
1 (1%)
0 (0%)
0 (0%)
Gastrointestinal
2 (1%)
4 (4%)
2 (2%)
reaction/hypersensitivity
(incl. drug fever)
Cytokine release
syndrome/acute infusion
reaction
Haemophagocytic
lymphohistiocytosis
PTLD (post-transplant
lymphoproliferative disease)
intravascular coagulation)
syndrome
haemorrhage
20
CHC n(%)
CHC n(%)
Reduced granulocytes
164 (86%)
84 (90%)
80 (92%)
Reduced haemoglobin
153 (81%)
75 (79%)
75 (85%)
Reduced leukocytes
170 (89%)
85 (89%)
82 (93%)
Reduced platelets
171 (90%)
91 (95%)
82 (93%)
Haemolysis
2 (1%)
0 (0%)
3 (4%)
Non-Haematologic toxicity
163 (86%)
75 (78%)
75 (84%)
Allergic
1 (1%)
0 (0%)
1 (1%)
1 (1%)
1 (1%)
1 (1%)
0 (0%)
0 (0%)
2 (3%)
1 (1%)
0 (0%)
6 (7%)
Serum sickness
0 (0%)
0 (0%)
0 (0%)
Arrhythmia
3 (2%)
1 (1%)
3 (4%)
Cardiac function
7 (4%)
1 (1%)
2 (3%)
DIC (disseminated
0 (0%)
0 (0%)
1 (1%)
Thrombotic microangiopathy 4 (2%)
0 (0%)
2 (2%)
Acute vascular leak
5 (3%)
3 (3%)
1 (1%)
Thrombosis/embolism
0 (0%)
0 (0%)
0 (0%)
Changes in the skin
4 (2%)
3 (3%)
8 (9%)
Diarrhoea
24 (13%)
14 (15%)
17 (19%)
Vomiting
24 (13%)
7 (7%)
18 (20%)
Stomatitis
124 (65%)
42 (44%)
49 (56%)
Nausea
70 (37%)
27 (28%)
32 (36%)
Colitis
5 (3%)
3 (3%)
3 (4%)
Ileus, gastrointestinal
3 (2%)
2 (2%)
4 (5%)
CNS haemorrhage
1 (1%)
0 (0%)
0 (0%)
Gastrointestinal
2 (1%)
4 (4%)
2 (2%)
reaction/hypersensitivity
(incl. drug fever)
Cytokine release
syndrome/acute infusion
reaction
Haemophagocytic
lymphohistiocytosis
PTLD (post-transplant
lymphoproliferative disease)
intravascular coagulation)
syndrome
haemorrhage
20