Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs

Table 1 Analysis of the characteristics reported most frequently in the complete data set

	Complete data set (n = 20,854)
Patients demographics
mean age (+/− standard deviation) [years]	8.5 (+/− 6.1)
median age (interquartile range) [years]	9.0 (2.0–14.0)
female	44.9% (n = 9354)
male	51.2% (n = 10,670)
unknown	4.0% (n = 830)
The five patient histories most frequently reported ^a
cases with information	47.7% (n = 9942)
1.	asthma (6.8%; 672/9942)
2.	premature baby (5.3%; 522/9942)
3.	rhinitis allergic (4.8%; 479/9942)
4.	seasonal allergy (4.7%; 469/9942)
5.	epilepsy (4.0%; 394/9942)
The five ADRs most frequently reported (SOC-level) ^a
1.	general disorders and administration site conditions (24.1%; n = 5030)
2.	nervous system disorders (20.6%; n = 4290)
3.	injury, poisoning and procedural complications (18.2%; n = 3785)
4.	gastrointestinal disorders (17.9%; n = 3733)
5.	skin and subcutaneous tissue disorders (17.2%; n = 3582)
The five ADRs most frequently reported (PT-level) ^a
1.	vomiting (5.4%; n = 1125)
2.	urticaria (4.6%; n = 954)
3.	dyspnoea (4.2%; n = 883)
4.	nausea (3.9%; n = 803)
5.	rash (3.1%; n = 637)
The five drug substances reported most frequently ^a
1.	methylphenidate (5.5%; n = 1151)
2.	ibuprofen (2.3%; n = 470)
3.	palivizumab (2.0%; n = 411)
4.	atomoxetine (2.0%; n = 407)
5.	etanercept (1.9%; n = 389)
The five application routes most often reported irrespective of the applied drug substance/substances ^b
1.	oral (41.9%; n = 8739)
2.	subcutaneous (11.0%; n = 2299)
3.	transplacental (10.5%; n = 2181)
4.	intravenous (8.0%; n = 1659)
5.	intramuscular (2.0%; n = 427)

^apresented are the five most frequently reported patient histories, ADRs and drug substances. Patients’ histories were analysed on the PT-level and ADRs on the PT- and the SOC-level of the MedDRA terminology [25]. Single drug substances and their combination products (if available) were summarized. One ADR report may contain information about more than one (i) pre-existing disease, (ii) ADR or (iii) drug substance, therefore, the number of reported patient histories, ADRs or drug substances may exceed that of the ADR reports
^bpresented are the five application routes most frequently reported irrespective of the applied drug substances and the number of applied drugs per ADR report. Multiple assignments are possible if one ADR report contains more than one drug referring to different application routes. 24.4% and 8.2% of the ADR reports contained drugs for which the application route was designated as not available or unknown
Table 1 presents patients demographics and histories, the ADRs on SOC- and PT-level of the MedDRA terminology, the drugs substances and the application routes most frequently reported in the complete data set

ISSN: 2050-6511