Skip to main content

Table 2 Safety summary (safety population)

From: A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers

Characteristic Powder formulation (n = 14) Caplet formulation (n = 14)
Participants with ≥ TEAE, n (%) 1 (7.1) 2 (14.3)
 TEAEs, n 1 3
Discontinuations due to TEAEs, n (%) 0 0
Treatment-related TEAEs, n (%) 1 (7.1) 1 (7.1)
SAEs, n (%) 0 0
Deaths, n (%) 0 0
TEAEs by preferred term, n (%)  
 Diarrhea 0 1 (7.1)
 Fatigue 1 (7.1) 0
 Increased ALT level 0 1 (7.1)
 Nausea 0 1 (7.1)
  1. ALT alanine aminotransferase, SAE serious adverse event, TEAE treatment-emergent adverse event