Table 2 Breakdown of adverse drug reactions.

From: Effects of the number of drugs used on the prevalence of adverse drug reactions in children

 

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)

  1. Each adverse drug reaction was counted, even when there is more than one adverse drug reaction per patient.
  2. *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.