TABLE 7

Adverse events

Severity
Grade 3–4Grade ≥2Grade 2Not specified
NigerCameroonUzbekistanSwazilandBangladeshNigerUzbekistanSwazilandCameroon
Allergic1 (2)13 (3)1 (2)
Hyperglycaemia21 (4)6 (9)
Gastrointestinal1 (2)1 (4)105 (21)9 (14)3 (13)#
Haematological2 (3)3 (5)2 (8)
Hepatic2 (8)1 (2)3 (13)1 (1)
Musculoskeletal2 (3)13 (3)5 (8)
Neurological3 (5)1 (4)10 (2)3 (5)1 (4)
Ophthalmological2 (3)1 (4)3 (1)1 (1)
Ototoxicity (hearing loss)9 (14)24 (23)§4 (17)24 (5)4 (6)2 (8)+22 (21)¶,§
Psychiatric2 (3)1 (4)1 (0)
Renal1 (1)2 (3)8 (13)2 (8)1 (1)

Data are presented as n (%). Bangladesh, n=493; Cameroon, n=150; Niger, n=65; Uzbekistan, n=64; Swaziland, n=24. #: study reported “many patients” experiencing nausea and vomiting, without specifying number; : hepatic: transaminitis necessitating discontinuation of pyrazinamide; ophthalmological: suspected retrobulbar neuritis necessitating discontinuation of ethambutol; ototoxicity: “mild” hearing loss; renal: hypercreatinaemia necessitating dose reduction of kanamycin; +: includes one participant with vestibular toxicity; §: denominator for ototoxicity is 106 participants who had two audiograms performed (at baseline and 4 months).