Table 3 Treatment emergent adverse events (AE) among Safety Population (n = 149)
TEAE, events/participants (% of participants) | |
|---|---|
Overall | 805/123 (83) |
Onset interval | |
Baseline to 4 weeks | 249/89 (60) |
4–8 weeks | 78/40 (27) |
8 weeks to 3 months | 55/36 (24) |
3–6 months | 133/53 (36) |
6–12 months | 141/59 (40) |
12–24 months | 147/45 (30) |
Age | |
< 65 years old | 322/50 (81) |
≥ 65 years old | 483/73 (84) |
Race | |
White | 720/113 (83) |
Non-white | 85/10 (77) |
Sex | |
Female | 472/81 (85) |
Male | 333/42 (78) |
Severity | |
Mild | 435/31 (21) |
Moderate | 242/49 (33) |
Severe | 100/36 (24) |
Potentially life threatening | 28/19 (13) |
Relatedness | |
Related to investigational product1 | 67/32 (22) |
Related to enema procedure1 | 44/24 (16) |
Related to C. difficile disease1 | 137/52 (35) |
Related to pre-existing condition1 | 388/87 (58) |
SAE, events/participants (% of participants) | |
Total | 208/52 (35) |
Related to investigational product | 9/2 (1) |
Related to enema procedure | 4/1 (1) |
Related to C. difficile disease | 31/16 (11) |
Related to pre-existing condition | 123/38 (26) |
Leading to death | 20/15 (10) |
Related to investigational product or procedure2 | 1/1 (1) |
Related to pre-existing condition | 12/11 (7) |