Table 2.
Incidence of treatment-emergent gastrointestinal adverse events occurring in >1 patient in either treatment group
| Adverse event, n (%) | Diclofenac topical solution (n = 465) | Oral diclofenac (n = 462) | P value |
|---|---|---|---|
| Any gastrointestinal disorder | 118 (25.4) | 180 (39.0) | <0.0001* |
| Dyspepsia | 51 (11.0) | 85 (18.4) | 0.001* |
| Diarrhea | 30 (6.5) | 62 (13.4) | 0.0004* |
| Abdominal distension | 28 (6.0) | 49 (10.6) | 0.01* |
| Abdominal pain upper | 26 (5.6) | 56 (12.1) | 0.0005* |
| Constipation | 24 (5.2) | 34 (7.4) | 0.17* |
| Nausea | 24 (5.2) | 43 (9.3) | 0.15* |
| Abdominal pain lower | 18 (3.9) | 25 (5.4) | 0.26* |
| Flatulence | 8 (1.7) | 9 (1.9) | 0.80* |
| Abdominal pain | 5 (1.1) | 12 (2.6) | 0.08* |
| Feces discolored | 5 (1.1) | 6 (1.3) | 0.75* |
| Vomiting | 5 (1.1) | 9 (1.9) | 0.28* |
| Breath odor | 4 (0.9) | 1 (0.2) | 0.37† |
| Abdominal discomfort | 3 (0.6) | 8 (1.7) | 0.13* |
| Dry mouth | 3 (0.6) | 1 (0.2) | 0.62† |
| Eructation | 3 (0.6) | 4 (0.9) | 0.72† |
| Epigastric discomfort | 1 (0.2) | 2 (0.4) | 0.62† |
| Gastrointestinal disorder | 0 (0.0) | 2 (0.4) | 0.25† |
| Hematochezia | 0 (0.0) | 2 (0.4) | 0.25† |
| Toothache | 0 (0.0) | 2 (0.4) | 0.25† |
Notes:
*
From Chi-square test;
†
From Fisher’s exact test.