Secondary outcome
gastritis-related symptoms, nausea, anxiety, vomiting, palpitation, skin rash
ADVERSE EVENTS, RECURRENCE, SIDE EFFECT
Overall compliance to the therapy was very good. The compliance to therapy was inadequate in 4 (0.3%) participants (1 in control group and 3 in PEP group) who stopped taking medication after day one either due to side effect or the anxiety related to the possible side effect. The drug was well tolerated and no serious adverse events were observed during the study period. Overall, 7 (0.6%) participants reported ADR, which was similar (P = 0.739) in the control (4, 0.7%) and PEP (3, 0.5%) groups. Most common ADR was gastritis-related symptoms in the form of epigastric abdominal discomfort with burning sensation, nausea and vomiting reported after loading dose by 4 participants (2 each from control and PEP group) which resolved with antacid without recurrence thereafter. Itching with skin rash over the foot was noticed in 2 participants (1 each from either group), which resolved spontaneously within few days after discontinuation of the study drug. Episode of palpitation was reported by one participant from PEP group during the follow-up. It was a single episode, self-limiting and lasted for less than a minute, for which no specific treatment was required, and there was no recurrence of episodes of palpitation thereafter.