Table 3.
Summary of TEAEs by MedDRA System Organ Class (Incidence ≥5%), Preferred Term (Incidence ≥2%), and Relationship to Study Drug (All Randomized Subjects, Irrespective of CDI Confirmation Status)a
| System Organ Class Preferred Term | Surotomycin (N = 305) |
Vancomycin (N = 286) |
||
|---|---|---|---|---|
| Related n (%) | Not Related n (%) | Related n (%) | Not Related n (%) | |
| Subjects with at least 1 TEAE | 24 (7.9) | 124 (40.7) | 26 (9.1) | 132 (46.2) |
| Cardiac disorders | 1 (0.3) | 17 (5.6) | 0 | 11 (3.8) |
| Gastrointestinal disorders | 13 (4.3) | 59 (19.3) | 12 (4.2) | 52 (18.2) |
| Abdominal pain | 2 (0.7) | 14 (4.6) | 3 (1.0) | 3 (1.0) |
| Constipation | 0 | 6 (2.0) | 1 (0.3) | 3 (1.0) |
| Diarrhea | 0 | 10 (3.3) | 0 | 14 (4.9) |
| Nausea | 6 (2.0) | 14 (4.6) | 5 (1.7) | 17 (5.9) |
| Vomiting | 4 (1.3) | 6 (2.0) | 0 | 10 (3.5) |
| General disorders and administration-site conditions | 1 (0.3) | 24 (7.9) | 1 (0.3) | 24 (8.4) |
| Edema peripheral | 0 | 4 (1.3) | 0 | 7 (2.4) |
| Infections and infestations | 0 | 45 (14.8) | 1 (0.3) | 40 (14.0) |
| Urinary tract infection | 0 | 15 (4.9) | 0 | 7 (2.4) |
| Investigations | 5 (1.6) | 18 (5.9) | 10 (3.5) | 19 (6.6) |
| Alanine aminotransferase increased | 3 (1.0) | 4 (1.3) | 6 (2.1) | 5 (1.7) |
| Metabolism and nutrition disorders | 1 (0.3) | 21 (6.9) | 2 (0.7) | 20 (7.0) |
| Dehydration | 0 | 4 (1.3) | 0 | 6 (2.1) |
| Hypokalemia | 0 | 5 (1.6) | 0 | 7 (2.4) |
| Musculoskeletal and connective tissue disorders | 0 | 8 (2.6) | 2 (0.7) | 17 (5.9) |
| Arthralgia | 0 | 0 | 0 | 6 (2.1) |
| Nervous system disorders | 1 (0.3) | 21 (6.9) | 4 (1.4) | 26 (9.1) |
| Headache | 1 (0.3) | 11 (3.6) | 1 (0.3) | 17 (5.9) |
Abbreviations: CDI, Clostridium difficile infection; MedDRA, Medical Dictionary for Regulatory Activities; TEAEs; treatment-emergent adverse events.
a
AEs with the relationship to study drug missing were considered to be related in this table. Subjects who experienced more than 1 event were counted only once per System Organ Class and Preferred Term using the greatest relationship to study drug. System Organ Classes and Preferred Terms were based on MedDRA dictionary, version 15.0.