Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

Table 2 Overview of adverse events (AE) other than adverse event of special interest (AESI) suspected related to APQ by System Organ Class and Preferred Term

System Organ Class (MedDRA) Preferred Term (MedDRA)	Safety population
System Organ Class (MedDRA) Preferred Term (MedDRA)	Patients^a N = 294	Events N = 46
Blood and lymphatic system disorders	4 (1.4%)	4
Haemolysis	2 (0.7%)	2
Anaemia	1 (0.3%)	1
Haemolytic anaemia	1 (0.3%)	1
Gastrointestinal disorders	16 (5.4%)	20
Vomiting	9 (3.1%)	9
Diarrhoea	4 (1.4%)	4
Abdominal pain	3 (1.0%)	3
Nausea	2 (0.7%)	2
Gastrointestinal pain	1 (0.3%)	2
General disorders and administration site conditions	2 (0.7%)	2
Asthenia	1 (0.3%)	1
Malaise	1 (0.3%)	1
Hepatobiliary disorders	2 (0.7%)	2
Hepatitis	1 (0.3%)	1
Hepatitis acute	1 (0.3%)	1
Infections and infestations	3 (1.0%)	3
Encephalitis brain stem	1 (0.3%)	1
Malaria	1 (0.3%)	1
Plasmodium falciparum infection	1 (0.3%)	1
Musculoskeletal and connective tissue disorders	4 (1.4%)	4
Back pain	2 (0.7%)	2
Myalgia	1 (0.3%)	1
Rhabdomyolysis	1 (0.3%)	1
Nervous system disorders	4 (1.4%)	7
Headache	3 (1.0%)	6
Insomnia	1 (0.3%)	1
Respiratory, thoracic and mediastinal disorders	2 (0.7%)	2
Dyspnoea	2 (0.7%)	2
Skin and subcutaneous tissue disorders	2 (0.7%)	2
Dry skin	1 (0.3%)	1
Pruritus	1 (0.3%)	1

An event is considered as suspected related to APQ if the relationship with APQ is 'related', 'suspected', 'unassessable' or 'missing' as reported by the investigator in the 'Adverse event' section of the CRF
AE Adverse event, SAE serious adverse event, AESI adverse event of special interest, APQ artenimol–piperaquine, MedDRA AEs are coded using MedDRA dictionary version 16.0
^aIf one patient presented an event several times (same preferred term), s/he is counted once for that term. The same rule applies for results by System Organ Class

ISSN: 1475-2875