Dimension | All patients | No diarrhea | All patients with diarrhea | Mild diarrhea | Moderate diarrhea | Severe diarrhea | ||
---|---|---|---|---|---|---|---|---|
Patient’s perception of having diarrhea | ||||||||
STIDAT | ||||||||
Diarrhea | 54/113 (47.8%) | 0/56 (0%) | 54/57 (94.7%) | 18/21 (85.7%) | 30/30 (100%) | 6/6 (100%) | ||
No diarrhea | 59/113 (52.2%) | 56/56 (100%) | 3/57 (5.3%) | 3/21 (14.3%) | 0/30 (0%) | 0/6 (0%) | ||
Diary | ||||||||
Diarrhea | 47/113 (41.6%) | 0/56 (0%) | 47/57 (82.5%) | 16/21 (76.2%) | 26/30 (86.7%) | 5/6 (83.3%) | ||
No diarrhea | 44/113 (38.9%) | 39/56 (69.6%) | 5/57 (8.8%) | 3/21 (14.3%) | 2/30 (6.7%) | 0/6 (0%) | ||
Unevaluable | 22/113 (19.5%) | 17/56 (30.4%) | 5/57 (8.78%) | 2/21 (9.5%) | 2/30 (6.6%) | 1/6 (16.7%) | ||
Mean number of bowel movements (SD) | ||||||||
STIDAT | 1.90 (1.31) | 1.55 (0.91) | 2.23 (1.55) | 1.60 (0.89) | 2.18 (1.43) | 4.58 (1.80) | ||
Diary | 1.90 (1.34) | 1.78 (1.18) | 1.99 (1.50) | 1.72 (1.42) | 1.89 (1.30) | 3.37 (2.13) | ||
Mean number of diarrheal episodes (SD) | ||||||||
STIDAT | 0.92 (1.46) | 0.003 (0.019) | 1.90 (1.60) | 1.11 (0.82) | 1.83 (1.22) | 4.58 (2.20) | ||
Diary | 0.73 (1.30) | 0.11 (0.44) | 1.38 (1.56) | 0.99 (1) | 1.22 (1.23) | 3.41 (3.40) | ||
Presence of urgency | ||||||||
STIDAT | ||||||||
Present | 58/113 (51.3%) | 14/56 (25%) | 44/57 (77.2%) | 16/21 (76.2%) | 23/30 (76.7%) | 5/6 (83.3%) | ||
Absent | 55/113(48.7%) | 42/56 (75%) | 13/57 (22.8%) | 5/21 (23.8%) | 7/30 (23.3%) | 1/6 (16.7%) | ||
Diary | ||||||||
Present | 64/113 (57.1%) | 17/56 (30.4%) | 46/57 (80.7%) | 14/21 (66.7%) | 26/30 (86.7%) | 6/6 (100%) | ||
Absent | 48/113 (42.9%) | 39/56 (69.6%) | 9/57 (15.8%) | 5/21 (23.8%) | 4/30 (13.3%) | 0/6 (100%) | ||
Unevaluable | 1/113 (0%) | 0/56 (0%) | 2/57 (3.6%) | 2/21 (9.5%) | 0/30 (0%) | 0/6 (100%) | ||
Presence of abdominal discomfort | ||||||||
STIDAT | ||||||||
Present | 52/113 (46.0%) | 18/56 (32.1%) | 34/57 (59.6%) | 9/21 (42.9%) | 19/30 (63.3%) | 6/6 (100%) | ||
Absent | 61/113 (55.0%) | 38/56 (67.9%) | 23/57 (40.4%) | 12/21 (57.1%) | 11/30 (36.7%) | 0/6 (100%) | ||
Diary | ||||||||
Present | 63/113 (55.8%) | 22/56 (39.3%) | 41/57 (71.9%) | 11/21 (52.4%) | 24/30 (80%) | 6/6 (100%) | ||
Absent | 49/113 (43.4%) | 34/56 (60.7%) | 15/57 (26.3%) | 9/21 (42.9%) | 6/30 (20%) | 0/6 (0%) | ||
Unevaluable | 1/113 (0.8%) | 0/56 (0%) | 1/57 (1.8%) | 1/21 (4.7%) | 0/30 (0%) | 0/6 (0%) | ||
Presence of abdominal spasms | ||||||||
STIDAT | ||||||||
Present | 39/113 (34.2%) | 11/56 (19.6%) | 28/57 (49.1%) | 9/21 (42.9%) | 14/30 (46.7%) | 5/6 (83.3%) | ||
Absent | 75/113 (66.8%) | 45/56 (80.4%) | 29/57 (50.9%) | 12 (57.1%) | 16/30 (53.3%) | 1/6 (16.7%) | ||
Diary | ||||||||
Present | 10/113 (8.8%) | 4/56 (7.1%) | 6/57 (10.5%) | 2/21 (9.5%) | 3/30 (10%) | 1/6 (16.7%) | ||
Absent | 102/113 (90.3%) | 52/56 (92.9%) | 50/57 (87.7%) | 18/21 (85.7%) | 27/30 (90%) | 5/6 (83.3%) | ||
Unevaluable | 1/113 (0.9%) | 0/56 (0%) | 1/57 (1.8%) | 1/21 (4.8%) | 0/30 (0%) | 0/6 (0%) | ||
Presence of fecal incontinence | ||||||||
STIDAT | ||||||||
Present | 13/113 (11.5%) | 4/56 (7.1%) | 9/57 (15.8%) | 2/21 (9.5%) | 6/30 (20%) | 1/6 (16.7%) | ||
Absent | 100/113 (88.5%) | 52/56 (93.9%) | 48/57 (84.2%) | 19/21 (90.5%) | 24/30 (80%) | 5/6 (83.3%) | ||
Diary | ||||||||
Present | 12/113 (10.6%) | 2/56 (3.6%) | 10/57 (17.5%) | 2/21 (9.5%) | 7/30 (23.3%) | 1/6 (16.7%) | ||
Absent | 100/113 (88.5%) | 54/56 (96.4%) | 45/57 (79.0%) | 17/21 (81.0%) | 23/30 (76.7%) | 5/6 (83.3%) | ||
Unevaluable | 1/113 (0.9%) | 0/56 (0%) | 2/57 (3.5%) | 2/21 (9.5%) | 0/30 (0%) | 0/6 (0%) | ||
Positive use of anti-diarrheals | ||||||||
STIDAT | ||||||||
Present | 7/113 (6.2%) | 0/56 (0%) | 7/57 (12.3%) | 0/21 (0%) | 6/30 (20%) | 1/6 (16.7%) | ||
Absent | 106/113 (93.8%) | 56/56 (100%) | 50/57 (87.7%) | 21/21 (100%) | 24/30 (80%) | 5/6 (83.3%) | ||
Diary | ||||||||
Present | 8/113 (7.1%) | 0/56 (0%) | 8/57 (14%) | 0/21 (0%) | 7/30 (23.3%) | 1/6 (16.7%) | ||
Absent | 103/113 (91.2%) | 56/56 (100%) | 47 (82.5%) | 19/21 (90.5%) | 23/30 (76.7%) | 5/6 (83.3%) | ||
Unevaluable | 2/113 (1.7%) | 0/56 (0%) | 2/57 (3.5%) | 2/21 (9.5%) | 0/30 (0%) | 0/6 (0%) | ||
Mean quality of life score (SD) | ||||||||
STIDAT | 8.1 (2.24) | 8.95 (1.70) | 7.34 (2.40) | 8.12 (1.63) | 7.1 (2.46) | 4.44 (2.77) | ||
EORTC QLQ-C30 | 6.7 (2.45) | 7.25 (2.40) | 6.12 (2.39) | 6.57 (2.44) | 6.20 (2.25) | 4.36 (2.50) |