A Phase IV Clinical Trial of Patients with Solid Tumors Receiving Lenograstim as Primary Prophylaxis for Chemotherapy-Induced Neutropenia, in a Docetaxel-Based Regimen
Table 5
Reasons for discontinuing treatment.
Assessment
Number (%) of patients
Completion of the regimen prescribed
Yes
314 (79.7)
No
80 (20.3)
Total
394 (100)
Reason why prescribed regimen* was not completed (if applicable)
Disease progression
16 (4.1)
Patient withdrew consent from study (will continue chemotherapy)
16 (4.1)
Patient withdrew consent from study (no further chemotherapy)
5 (1.2)
Adverse experience (excluding toxicities**)
17 (4.3)
Toxicities**
0 (0.0)
Death
13 (3.3)
Other***
13 (3.3)
For some patients, reason listed above was linked to docetaxel or lenograstim
Docetaxel related
23 (5.8)
Lenograstim related
21 (5.3)
Reasons for lenograstim-related withdrawal:
Patient withdrew consent from study (will continue chemotherapy)
11 (2.8)
Patient withdrew consent from study (no further chemotherapy)
1 (0.0)
Adverse experience (excluding toxicities**)
6 (1.5)
Toxicity**
0 (0.0)
Death
1 (0.0)
Other
2 (0.0)
The percentage is calculated out of the 394, the total number of patients in the study’s cohort.
*Docetaxel-based regimen or lenograstim.
**Toxicities: as specified according to the secondary objectives of the study: neutropenia, asthenia, anemia, anorexia, myalgia, oral mucositis, and nail changes.
***Other: medical funder related (4), investigator’s decision (5), protocol violation (2), treatment delay due to hospitalization (1), and affordability (1).
