Table 2.
Number of treatment emergent adverse events of interest based on grade among adolescents who initiated injectable-free regimens containing bedaquiline and/or delamanid between February 2015 and June 2018 in Khayelitsha, South Africa.
| Adverse Events of Interest | Median (IQR) time to onset (months) | Grade 1 Instances/Patient N/N (%) | Grade 2 Instances/Patient N/N (%) |
Grade 3 Instances/Patient N/N (%) |
Grade 4 Instances/Patient N/N (%) |
Total Instances/Patient N/N (%) |
|---|---|---|---|---|---|---|
| Alanine aminotransferase increased | 2·2 (1·5–3·5) | 8 n = 4 (18%) |
2 n = 2 (9%) |
0 | 0 | 10 n = 4 (18%) |
| White blood cell decreased | 6·4 (1·80–19·0) | 14 n = 6 (27%) |
0 | 0 | 0 | 14 n = 6 (27%) |
| Anaemia | 2·4 (1·8–4·6) | 8 n = 5 (23%) |
8 n = 6 (27%) |
3 n = 2 (9%) |
1 n = 1 (5%) |
20 n = 7 (32%) |
| Thrombocytopaenia | 1·3 | 0 | 0 | 0 | 1 n = 1 (5%) |
1 n = 1 (5%) |
| QTcF prolongation | 3·0 (2·0–4·5) | 4 n = 4 (18%) |
0 | 0 | 0 | 4 n = 4 (18%) |
| Total of each grade | 3·0 (1·8–6·5) | 34 n= 16 (73%) |
10 n = 7 (32%) |
3 n = 2 (9%) |
2 n = 2 (9%) |
49 n = 17 (77%) |
Abbreviations: IQR, interquartile range; QTcF, QT corrected using the Frederica formula.