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 𝑛 (%)	Grade 3 𝑛 (%)	Grade 4 𝑛 (%)	Grade 5 𝑛 (%)
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.