Table 4.
Serious Adverse Events by Study Arm.
| Arm | Patient | Event | Days from Enrollment to Event |
Primary Diagnosis | Attribution to Study Drugs |
Grade |
|---|---|---|---|---|---|---|
| EMB | P1 | Hospitalization | 68 | Cutaneous reaction | Probably Related |
3 |
| P2 | Death | 268 | Gunshot wound | Not related | 5 | |
| P3 | Death | 65 | Gunshot wound | Not related | 5 | |
| P4 | Death | 31 | Tuberculosis | Not related | 5 | |
| P5 | Hospitalization | 171 | Polyneuropathy | Not related | 3 | |
| Death | 240 | Unknown | Not related | 5 | ||
| P6 | Hospitalization | 84 | Unilateral leg edema | Not related | 2 | |
| Death | 95 | Subdural hemorrhage | Not related | 5 | ||
| MOX | P7 | Hospitalization | 31 | Community acquired pneumonia |
Not related | 3 |
| Hospitalization | 377 | Pulmonary abscess | Not related | 2 | ||
| P8 | Death | 242 | Urinary sepsis | Not related | 5 | |
| P9 | Hospitalization | 57 | Spontaneous abortion | Not related | N/A | |
| P10 | Death | 372 | Gunshot wound | Not related | 5 | |
| P11 | Hospitalization | 19 | Dysphasia | Not related | 4 | |
| Death | 61 | Esophageal neoplasm | Not related | 5 | ||
| P12 | Grade 4 Toxicity |
69 | Proteinuria | Not related | 4 |