Clinical Study

Sustained Release Formulation of Primaquine for Prevention of Relapse of Plasmodium vivax Malaria: A Randomized, Double-Blind, Comparative, Multicentric Study

Table 4

Numbers of AEs reported during chloroquine therapy and primaquine therapy.

Adverse event Chloroquine therapy
total ()
Primaquine therapy
P 15 mg
()
PSR 15 mg
()
PSR 30 mg
()
Total
()

Malaise23418
Headache41225
Nausea122114
Decreased appetite80303
Pyrexia11113
Vomiting51113
Dizziness00112
Myalgia02002
Asthenia00112
Arthralgia00101
Pruritus50011
Haemoglobin decreased00011
Muscle spasms00101
Dyspnoea exertional00101
Dyspepsia00011
Diarrhoea00101
Diarrhoea10000
Cough10000
Total events3910181139
Total patients, (%)23 (6.4)5 (4.2)10 (8.5)6 (5.0)21 (5.9)

P 15 mg: conventional primaquine 15 mg, PSR 15 mg: primaquine sustained release 15 mg, and PSR 30 mg: primaquine sustained release 30 mg.
value: P 15 mg versus PSR 15 mg (), P 15 mg versus PSR 30 mg (), and PSR 15 mg versus PSR 30 mg () (for patients reporting adverse events).