Table 2.

Breakdown of adverse drug reactions.

	n = 54
	Number of events (%)
A. Assessment of the causality of adverse drug reactions
Certain	6 (11.1)
Probable/ likely	12 (22.2)
Possible	36 (66.7)
B. Classification of adverse drug reactions
Gastrointestinal disorders	23 (42.6)
Skin and subcutaneous tissue disorders	9 (16.7)
Investigations	6 (11.1)
Infections and infestations	4 (7.4)
General disorders and administration site conditions	3 (5.6)
Nervous system disorders	3 (5.6)
Metabolism and nutrition disorders	2 (3.7)
Blood and lymphatic system disorders	1 (1.9)
Immune system disorders	1 (1.9)
Psychiatric disorders	1 (1.9)
Respiratory, Thoracic and mediastinal disorders	1 (1.9)
C. Severity of adverse drug reactions*
Grade 1	31 (57.4)
Grade 2	13 (24.1)
Grade 3	10 (18.5)
Grade 4	0 (0)
Grade 5	0 (0)
D. Classification of suspected drugs related to adverse drug reactions
Antiinfectives for systemic use	30 (55.6)
Respiratory system	10 (18.5)
Antineoplastic and immunomodulating agents	8 (14.8)
Nervous system	4 (7.4)
Alimentary tract and metabolism	1 (1.9)
Blood and blood forming organs	1 (1.9)

Each adverse drug reaction was counted, even when there is more than one adverse drug reaction per patient.

*Grade refers to the severity of the adverse events according to Common Terminology Criteria for Adverse Events v5.0. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily life. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily life. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.