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 3
Adverse effects not related to primary and secondary objectives, regardless relationship with chemotherapy.
Adverse effect
All Grades (%)
Grade 3 (%)
Grade 4 (%)
Grade 5 (%)
Embolism
1 (0.25)
—
—
1 (0.25)
Intracranial haemorrhage
1 (0.25)
—
—
1 (0.25)
Abdominal pain/discomfort
69 (17.5)
4 (1.0)
—
—
Alopecia
69 (17.5)
1 (0.25)
—
—
Arthralgia
36 (9.1)
2 (0.5)
—
—
Back pain
56 (14.2)
5 (1.2)
—
—
Bone pain
29 (7.3)
4 (1.0)
—
—
Constipation
88 (22.3)
1 (0.25)
—
—
Diarrhoea
138 (35.0)
8 (2.0)
1 (0.25)
—
Disease progression
18 (4.6)
1 (0.25)
2 (0.5)
—
Dizziness
23 (5.8)
2 (0.5)
1 (0.25)
—
Drug hypersensitivity
10 (2.5)
1 (0.25)
1 (0.25)
—
Dyspnoea
40 (10.2)
5 (1.2)
1 (0.25)
—
Fatigue
74 (18.8)
3 (0.8)
—
—
Flushing
37 (9.4)
2 (0.5)
—
—
Headache
71 (18.0)
—
1 (0.25)
—
Insomnia
40 (10.2)
1 (0.25)
—
—
Nausea
130 (33.0)
3 (0.8)
—
—
Peripheral neuropathy
33 (8.4)
2 (0.5)
—
—
Oedema
77 (19.5)
1 (0.25)
—
—
Oropharyngeal pain
31 (7.9)
1 (0.25)
—
—
Pain
57 (14.5)
2 (0.5)
—
—
Palmar-plantar erythrodysaesthesia syndrome
11 (2.8)
2 (0.5)
—
—
Cough
26 (6.6)
1 (0.25)
—
—
Pyrexia
13 (3.3)
—
1
—
Rash
59 (15.0)
2 (0.5)
—
—
Skin changes
25 (6.3)
4 (1.0)
—
—
Vomiting
40 (10.2)
5 (1.2)
—
—
Decreased white cell count
11 (2.8)
1 (0.25)
—
—
The percentage is calculated out of the 394, the total number of patients in the study’s cohort. Adverse effects are listed which occurred in more than 10 patients and with at least one reported grade 3–5 event.