Table 4. Adverse events and use of concomitant medications in test and control groups.
| Test (N=35) | Control (N=36) | P value (Fisher’s exact test) | |
|---|---|---|---|
| Adverse events, N (%) | |||
| Overall | |||
| Any adverse event | 20 (57.1%) | 23 (65.7%) | 0.624 |
| Severity | |||
| Mild | 15 (42.9%) | 15 (42.9%) | |
| Moderate | 4 (11.4%) | 7 (20.0%) | |
| Severea | 1 (2.9%) | 1 (2.9%) | |
| Preferred term descriptionb | |||
| Gastrointestinal disorders | 11 (31.4%) | 13 (37.1%) | 0.802 |
| Infections and infestations | 10 (28.6%) | 12 (34.3%) | 0.797 |
| Concomitant medication, N (%) | |||
| Overall | |||
| Any concomitant medication | 21 (60.0%) | 28 (80.0%) | 0.117 |
| Subcategoryc | |||
| Anti-infectives for systemic use | 3 (8.6%) | 12 (34.4%) | 0.018 |
a
Reported severe adverse events were feeding disorder of infancy or early childhood (test group) and bronchiolitis and feeding disorder of infancy or early childhood (control group).
b
The two most frequently reported preferred terms of adverse event are shown.
c
Only categories (of total nine categories) with a statistically significant difference (P<0.05) are shown.