Table 6.
Occurrence and severity of anticipated adverse events
|
NaP (n = 40) |
PEG (n = 40) |
||||||||
| Mild | Moderate | Severe | Occurrence (%)1 | Mild | Moderate | Severe | Occurrence (%)1 | P2 | |
| Nausea | 17 | 0 | 1 | 18 (45) | 14 | 4 | 0 | 18 (45) | 1.000 |
| Vomiting | 9 | 1 | 0 | 10 (25) | 5 | 4 | 0 | 9 (22.5) | 1.000 |
| Abdominal bloating | 16 | 2 | 0 | 18 (45) | 12 | 0 | 0 | 12 (30) | 0.248 |
| Abdominal pain | 14 | 1 | 1 | 16 (40) | 11 | 0 | 0 | 11 (27.5) | 0.344 |
| Anal irritation | 13 | 3 | 0 | 16 (40) | 10 | 1 | 1 | 12 (30) | 0.482 |
| Dizziness | 13 | 2 | 1 | 16 (40) | 10 | 1 | 0 | 11 (27.5) | 0.344 |
| Chills | 3 | 0 | 1 | 4 (10) | 3 | 0 | 0 | 3 (7.5) | 1.000 |
| Hunger pains | 7 | 0 | 0 | 7 (17.5) | 7 | 0 | 0 | 7 (17.5) | 1.000 |
| Headache | 6 | 1 | 0 | 7 (17.5) | 6 | 0 | 0 | 6 (15) | 1.000 |
| Insomnia3 | 4 | 1 | 0 | 5 (12.8) | 2 | 0 | 0 | 2 (5) | 0.263 |
| Total | 11 | 4 | 117 | 11 | 80 | 10 | 1 | 91 | |
1
Occurrence rate was calculated by “frequency of occurrence/total number of subject”. 2Fisher’s exact test for occurrence frequency of adverse events.
3
One patient in NaP group was taking Lorazepan (Ativan, Wyeth, USA) for insomnia during the bowel preparation, therefore this event was not assessable for this patient.