Table 6 Adverse events observed during the study
From: Randomized double blind clinical trial on the effect of oral α-cyclodextrin on serum lipids
Adverse Events | Probably/possible related AE | ||||
|---|---|---|---|---|---|
A.E. (Total n = 35) | n | % | Study arma | ||
Expected AE | 10 | 28.6 | α-CD | Placebo | |
Probably related AE | 9 | 25.7 | Abdominal Pain | 1 | 1 |
Possibly related AE | 2 | 5.7 | Intestinal Gas | 3 | 0 |
Unrelated | 14 | 40.0 | Nausea | 1 | 0 |
Diarrhea | 2 | 1 | |||
S.A.E (Total n = 2) | n | % | Urinary Urgency | 0 | 1 |
Expected SAE | 0 | 0 | Dyspepsia | 2 | 0 |
Related SAE | 0 | 0 | Cramps | 1 | 0 |
Unrelated | 2 | 100 | Increased frequency | 1 | 0 |