TABLE 2.
Frequency of solicited signs and symptoms by cohort
| Characteristic or sign | Value for cohort (n) |
||||
|---|---|---|---|---|---|
| Cohort 1 (10) | Cohort 2 (10) | Cohort 3 (10) | Cohort 4 (10) | Cohort 5 (16) | |
| Target dose (actual dose) (CFU) | 500 (567) | 1,000 (817) | 1,000 (913) | 1,500 (1,760) | 1,500 (1,100) |
| Any diarrhea [n (%)] | 2 (20.0) | 6 (60.0) | 7 (70.0) | 7 (70.0) | 12 (75.0) |
| Moderate or severe diarrhea [n (%)] | 0 (0.0) | 5 (50) | 5 (50) | 7 (70) | 8 (50) |
| Dysentery [n (%)] | 0 (0.0) | 6 (60.0) | 3 (30.0) | 5 (50.0) | 6 (37.5) |
| Vomiting [n (%)] | 0 (0.0) | 4 (40.0) | 1 (10.0) | 1 (10.0) | 3 (18.8) |
| Headache [n (%)] | 5 (50.0) | 7 (70.0) | 8 (80.0) | 7 (70.0) | 10 (62.5) |
| Nausea [n (%)] | 0 (0.0) | 4 (40.0) | 3 (30.0) | 3 (30.0) | 4 (25.0) |
| Abdominal pain [n (%)] | 1 (10.0) | 9 (90.0) | 7 (70.0) | 7 (70.0) | 9 (56.3) |
| Gas [n (%)] | 1 (10.0) | 8 (80.0) | 5 (50.0) | 4 (40.0) | 3 (18.8) |
| Myalgia [n (%)] | 1 (10.0) | 7 (70.0) | 7 (70.0) | 3 (30.0) | 5 (31.3) |
| Malaise [n (%)] | 0 (0.0) | 8 (80.0) | 8 (80.0) | 3 (30.0) | 1 (6.3) |
| Anorexia [n (%)] | 1 (10.0) | 9 (90.0) | 2 (20.0) | 4 (40.0) | 4 (25.0) |
| Arthralgia [n (%)] | 0 (0.0) | 7 (70.0) | 1 (10.0) | 3 (30.0) | 1 (6.3) |
| Fever [n (%)] | 0 (0.0) | 3 (30.0) | 1 (10.0) | 4 (40.0) | 3 (18.8) |
| S. sonnei in stool | 5 (50) | 7 (70) | 10 (100) | 10 (100) | 14 (88) |
| Median (Q1, Q3) time to diarrhea onset (h)a | 108.2 (101.5, 114.9) | 45.2 (39.1, 51.0) | 55.9 (48.5, 76.2) | 35.8 (13.1, 52.1) | 38.6 (31.7, 65.5) |
| Median (Q1, Q3) maximum 24-h no. of loose/liquid stoolsa | 5 (4, 5) | 7 (4, 8) | 4 (3, 9) | 10 (8, 12) | 7 (2, 10) |
| Median (Q1, Q3) maximum 24-h vol (ml) of loose/liquid stoolsa | 454 (319, 588) | 710 (326, 1125) | 616 (342, 1205) | 846 (472, 1092) | 968 (179, 1190) |
| Median (Q1, Q3) total no. of loose/liquid stoolsa | 5 (5, 5) | 14 (7, 20) | 5 (4, 18) | 21 (13, 23) | 14 (3, 26) |
| Median (Q1, Q3) total vol (ml) of loose/liquid stoolsa | 495 (319, 670) | 1419 (598, 1916) | 691 (591, 2562) | 1589 (1020, 2256) | 1425 (211, 2596) |
| Shigellosis per protocol [n (%)]b | 0 (0.0) | 2 (20.0) | 1 (10.0) | 4 (40.0) | 2 (12.5) |
| Alternative endpoint 1 [n (%)]c | 0 (0.0) | 6 (60.0) | 4 (40.0) | 7 (70.0) | 7 (43.8) |
| Alternative endpoint 2 [n (%)]d | 0 (0.0) | 5 (50.0) | 3 (30.0) | 6 (60.0) | 7 (43.8) |
a
Limited to subjects with diarrhea and excluding subjects with loose stools not meeting the diarrhea definition.
b
Shedding of S. sonnei in the stool and moderate-severe diarrhea (and/or dysentery) plus either moderate fever or one or more severe intestinal symptoms.
c
Shedding of S. sonnei in the stool and either (i) severe diarrhea (ii) moderate diarrhea and fever, or (iii) moderate diarrhea with ≥1 moderate constitutional/enteric symptom or dysentery.
d
Shedding of S. sonnei and either (i) severe diarrhea, (ii) moderate diarrhea and fever, (iii) dysentery and fever, (iv) moderate diarrhea and ≥1 severe constitutional/enteric symptom, or (v) dysentery and ≥1 severe constitutional/enteric symptom.