Table 3.
Adverse Events Among Children with Multidrug-Resistant/Rifampicin-Resistant Tuberculosis (N = 15) at Least Possibly Attributed to Bedaquiline
| Adverse Effects Possibly, Probably, Definitely Attributed to Bedaquiline by Grade | ||||||
|---|---|---|---|---|---|---|
| Adverse Event | No. of Patients With Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total No. of events |
| Gastrointestinal disorders | ||||||
| Vomiting | 4 | 4 | 1 | 0 | 0 | 5 |
| Abdominal Pain | 1 | 1 | 0 | 0 | 0 | 1 |
| Nausea | 2 | 2 | 0 | 0 | 0 | 2 |
| Hepatobiliary disorders | ||||||
| ALT, high | 4 | 3 | 2 | 0 | 0 | 5 |
| Skin disorders | ||||||
| Pruritus | 1 | 1 | 0 | 0 | 0 | 1 |
| Acneiform rash | 3 | 3 | 0 | 0 | 0 | 3 |
| Other | ||||||
| Arthritis | 2 | 0 | 1 | 1 | 0 | 2 |
| Arthralgia | 2 | 1 | 0 | 1 | 0 | 2 |
| Headache | 2 | 1 | 1 | 0 | 0 | 2 |
| Syncope | 1 | 0 | 1 | 0 | 0 | 1 |
| QT prolongation | 2 | 2 | 0 | 0 | 0 | 2 |
| Chest pain | 1 | 0 | 1 | 0 | 0 | 1 |
| Elevated lactate | 1 | 1 | 0 | 0 | 0 | 1 |
| Fatigue | 1 | 0 | 1 | 0 | 0 | 1 |
Abbreviations: ALT, alanine transaminase; QTcF, QT interval corrected for heart rate using Fridericia’s formula.