Table 3.
Experimental Group *, † | Control Group *, ‡ | Comparator Group †, ‡ | * p | † p | ‡ p | |
---|---|---|---|---|---|---|
Full analysis set | (n = 63, %) | (n = 57, %) | (n = 58, %) | - | - | - |
Loss of appetite | - | - | - | 0.887 1 | 0.318 1 | 0.269 1 |
0 (none) | 57 (90.5) | 52 (91.2) | 49 (84.5) | - | - | - |
1 (mild) | 6 (9.5) | 5 (8.8) | 9 (15.5) | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Abdominal pain | - | - | - | 0.832 1 | 0.007 1 | 0.005 1 |
0 (none) | 51 (81.0) | 47 (82.5) | 34 (58.6) | - | - | - |
1 (mild) | 12 (19.0) | 10 (17.5) | 24 (41.4) | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Vomiting | - | - | - | 0.497 2 | 0.497 2 | N/A |
0 (none) | 61 (96.8) | 57 (100.0) | 58 (100.0) | - | - | - |
1 (mild) | 2 (3.2) | 0 | 0 | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Abdominal distention | - | - | - | 0.990 1 | 0.175 1 | 0.184 1 |
0 (none) | 53 (84.1) | 48 (84.2) | 43 (74.1) | - | - | - |
1 (mild) | 10 (15.9) | 9 (15.8) | 15 (25.9) | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Fever higher than 38 °C | - | - | - | N/A | N/A | N/A |
0 (none) | 63 (100.0) | 57 (100.0) | 58 (100.0) | - | - | - |
1 (mild) | 0 | 0 | - | - | - | - |
2 (moderate) | 0 | 0 | - | - | - | - |
3 (severe) | 0 | 0 | - | - | - | - |
Per protocol set | (n = 60, %) | (n = 56, %) | (n = 58, %) | - | - | - |
Loss of appetite | - | - | 0.844 1 | 0.368 1 | 0.284 1 | |
0 (none) | 54 (90.0) | 51 (91.1) | 49 (84.5) | - | - | - |
1 (mild) | 6 (10.0) | 5 (8.9) | 9 (15.5) | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Abdominal pain | - | - | - | 0.947 1 | 0.006 1 | 0.006 1 |
0 (none) | 49 (81.7) | 46 (82.1) | 34 (58.6) | - | - | - |
1 (mild) | 11 (18.3) | 10 (17.9) | 24 (41.4) | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Vomiting | - | - | - | >0.999 2 | >0.999 2 | N/A |
0 (none) | 59 (98.3) | 56 (100.0) | 58 (100.0) | - | - | - |
1 (mild) | 1 (1.7) | 0 | 0 | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
Abdominal distention | - | - | - | 0.931 1 | 0.222 1 | 0.200 1 |
0 (none) | 50 (83.3) | 47 (83.9) | 43 (74.1) | - | - | - |
1 (mild) | 10 (16.7) | 9 (16.1) | 15 (25.9) | - | - | - |
2 (moderate) | 0 | 0 | - | - | - | - |
3 (severe) | 0 | 0 | - | - | - | - |
Fever higher than 38 °C | - | - | - | N/A | N/A | N/A |
0 (none) | 60 (100.0) | 56 (100.0) | 58 (100.0) | - | - | - |
1 (mild) | 0 | 0 | 0 | - | - | - |
2 (moderate) | 0 | 0 | 0 | - | - | - |
3 (severe) | 0 | 0 | 0 | - | - | - |
∗,†,‡ Comparisons between the two groups with the same symbol. 1 Chi-squared or 2 Fisher’s exact test was used. Abbreviations: N/A, not applicable.