Table 4

AEs occurring during the HBOT study

HBOT (n = 49)Total eventsControl (n = 54)Total eventsP value
Solicited AEs
 Acute respiratory distress0000
 Pneumothorax0000
 Convulsion/seizure0000
 Barotraumas4 (8.2)53 (5.6)3
 Visual changes4 (8.2)43 (5.6)3
 Total solicited AEs8 (16.3)96 (11.1)60.441
Unsolicited AEs
 Unable to equalize ears5 (10.2)90 (0)0
 Anxiety, chest pain2 (4.1)20 (0)0
 Nausea4 (8.2)52 (3.7)2
 Hypo/hyperglycemia4 (8.2)42 (3.7)2
 Wound infection2 (4.1)21 (1.9)1
 Pain postmyringotomy1 (2.0)10 (0)0
 Congestive heart failure1 (2.0)10 (0)0
 Total unsolicited AEs13 (26.5)245 (9.3)50.021
Total any AEs20* (40.1)3311 (20.4)11
  • Data are n (%) or n. AE, adverse event.

  • *Patients reported more than one AE.