Table 2.
Treatment-emergent Adverse Events by Preferred Term (Safety Analysis Set)
| TEAEa | Fidaxomicin (n = 98) | Vancomycin (n = 44) | ||
|---|---|---|---|---|
| Patients, No. (%) | Events, No. | Patients, No. (%) | Events, No. | |
| Any TEAE, all patients | 72 (73.5) | 303 | 33 (75.0) | 126 |
| Pyrexia | 13 (13.3) | 20 | 10 (22.7) | 13 |
| Abdominal pain | 5 (5.1) | 6 | 9 (20.5) | 11 |
| Vomiting | 7 (7.1) | 8 | 6 (13.6) | 8 |
| Diarrhea | 7 (7.1) | 7 | 5 (11.4) | 6 |
| Headache | 8 (8.2) | 12 | 0 | 0 |
| Constipation | 5 (5.1) | 6 | 1 (2.3) | 1 |
| Oral candidiasis | 3 (3.1) | 3 | 3 (6.8) | 3 |
| Pruritus | 3 (3.1) | 3 | 3 (6.8) | 3 |
| Any TEAE by age group | ||||
| ≥2 to <18 y | 59 (75.6) | 225 | 27 (79.4) | 113 |
| <2 y | 13 (65.0) | 78 | 6 (60.0) | 13 |
| ≥2 to <6 y | 23 (71.9) | 103 | 13 (81.3) | 44 |
| ≥6 to <12 y | 21 (80.8) | 60 | 7 (70.0) | 33 |
| ≥12 to <18 y | 15 (75.0) | 62 | 7 (87.5) | 36 |
| Drug-related TEAE | 7 (7.1) | 7 | 5 (11.4) | 5 |
| Constipation | 2 (2.0) | 2 | 0 | 0 |
| Abdominal pain | 0 | 0 | 1 (2.3) | 1 |
| Diarrhea | 1 (1.0) | 1 | 0 | 0 |
| Vomiting | 0 | 0 | 1 (2.3) | 1 |
| Pyrexia | 1 (1) | 1 | 0 | 0 |
| Oral candidiasis | 1 (1) | 1 | 1 (2.3) | 1 |
| Vulvovaginal mycotic infection | 0 | 0 | 1 (2.3) | 1 |
| Elevated ALT level | 1 (1.0) | 1 | 0 | 0 |
| Irritability | 1 (1.0) | 1 | 0 | 0 |
| Hypotension | 0 | 0 | 1 (2.3) | 1 |
| Serious TEAE | 24 (24.5) | 43 | 12 (27.3) | 16 |
| Drug-related serious TEAE | 0 | 0 | 0 | 0 |
| TEAE leading to death | 3 (3.1) | 5 | 0b | 0 |
| TEAE leading to withdrawal of treatment | 1 (1.0) | 1 | 1 (2.3) | 1 |
| TEAE of special interest | ||||
| Hypersensitivity | 9 (9.2) | 12 | 4 (9.1) | 4 |
| Hematological AE (decrease in WBC, neutrophil, and lymphocyte counts) | 12 (12.2) | 43 | 4 (9.1) | 6 |
| Renal AE (renal laboratory value abnormalities) | 5 (5.1) | 5 | 1 (2.3) | 1 |
| Gastrointestinal hemorrhage | 1 (1.0) | 1 | 0 | 0 |
| QT prolongation | 0 | 0 | 0 | 0 |
| Hepatic laboratory value abnormalities/potential drug-induced liver injuryc | 5 (5.1) | 7 | 1 (2.3) | 1 |
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; QT, Q wave to the end of the T wave; TEAE, treatment-emergent AE; WBC, white blood cell.
aIndividual TEAEs presented are those experienced by ≥5% patients in either treatment arm.
bTwo patients in the vancomycin arm died after the end of the study, on days 43 and 47, from causes unrelated to treatment.
cDrug-induced liver injury was defined as moderate (ALT or aspartate aminotransferase [AST] >3 times the upper limit of normal [ULN] or total bilirubin >2 times ULN) or severe (ALT or AST >3 times ULN and total bilirubin >2 times ULN). In addition, the patient was considered to have severe hepatic abnormalities if any of the following was observed: ALT or AST >8 times ULN; ALT or AST >5 times ULN for >2 weeks; ALT or AST >3 times ULN and international normalized ratio (INR) >1.5 (if INR testing was applicable/evaluated); or ALT or AST >3 times ULN with fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%).