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ALIQOPA(copanlisib)for injection, for intravenous use(七)
2018-06-22 02:21:27 来源: 作者: 【 】 浏览:10915次 评论:0
6.1 Clinical Trials Experience 
 
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in the general patient population.
 
The safety data reflect exposure to ALIQOPA in 168 adults with follicular lymphoma and other hematologic malignancies treated with ALIQOPA 60 mg or 0.8 mg/kg equivalent in clinical trials. The median duration of treatment was 22 weeks (range 1 to 206 weeks). 
 
Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). The most common adverse reactions (≥20%) were hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia. 
 
Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most common reasons for dose reduction were hyperglycemia (7%), neutropenia (5%), and hypertension (5%). The most common reasons for drug discontinuation were pneumonitis (2%) and hyperglycemia (2%).
 
Table 2 provides the adverse reactions occurring in at least 10% of patients receiving ALIQOPA monotherapy, and Table 3 provides the treatment-emergent laboratory abnormalities in ≥20% of patients and ≥4% of Grade ≥3 treated with ALIQOPA.
Table 2: Adverse Reactions Reported in ≥10% of Patients with Follicular Lymphoma and Other Hematological Malignancies Treated with ALIQOPA  
 
ADVERSE REACTIONS 
 
Copanlisib  
 
N = 168 
 
 
Any Grade 
 
n (%) 
 
Grade 3 
 
n (%) 
 
Grade 4 
 
n (%) 
 
Metabolism and nutrition disorders  
    
  Hyperglycemia  
90 (54%)
 
56 (33%)
 
10 (6%)
 
Blood and lymphatic system disorders 
    
  Leukopenia  
61 (36%)
 
20 (12%) 
 
26 (15%) 
 
  Neutropenia (including febrile neutropenia)  
53 (32%) 
 
16 (10%) 
 
26 (15%) 
 
  Thrombocytopenia  
37 (22%)
 
12 (7%)
 
2 (1%)
 
General disorders and administration site conditions 
    
  Decreased general strength and energy (includes fatigue and asthenia)  
61 (36%)
 
6 (4%)
 
0
Gastrointestinal disorders 
    
Diarrhea  
60 (36%)
 
8 (5%)
 
0
 
Nausea  
43 (26%)
 
1 (<1%)
 
0
Stomatitis (includes oropharyngeal erosion and ulcer, oral pain)  
24 (14%)
 
3 (2%)
&n
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