Table 3:

Hepatotoxicity resulting in isoniazid discontinuation, and serious adverse events

	Group 1 (n=169)	Group 2 (n=169)	Group 3 (n=170)	Group 4 (n=172)	Total (n=680)
Adverse events
All grade 3 and higher adverse events	18 (10·7%)	14 (8·3%)	25 (14·7%)	13 (7·6%)	70 (10·3%)
Hepatotoxicity resulting in isoniazid discontinuation (grade 3 or higher hepatotoxicity)*	13 (7·7%)	10 (5·9%)	15 (8·8%)	9 (5·2%)	47 (6·9%)
Other grade 3 or higher adverse events resulting in isoniazid discontinuation (ie, not due to hepatotoxicity)	1 (0·6%)	2 (1·2%)	3 (1·8%)	0	6 (0·1%)
Serious adverse events
Severe hepatotoxicity (grade 4)	3 (1·8%)	2 (1·2%)	3 (1·8%)	3† (1·7%)	11 (1·6%)
Hospitalisation
Unrelated to isoniazid	1 (0·6%)	2 (1·2%)	2 (1·2%)	1 (0·6%)	6 (0·9%)
Possibly related to isoniazid	0	1‡ (0·6%)	0	0	1 (0·1%)
Death§	1 (0·6%)	0	4 (2·4%)	0	5 (0·7%)
Total serious adverse events	5 (3·0%)	5 (3·0%)	9 (5·3%)	4 (2·3%)	23 (3·4%)

^*Grade 3 hepatotoxicity defined by laboratory or clinical criteria as alanine aminotransferase or aspartate aminotransferase elevation ≥5 (but <10) times the upper limit of normal or symptoms consistent with hepatotoxicity; and grade 4 as ≥10 times the upper limit of normal or potentially life-threatening symptoms.

^†Two participants with severe hepatotoxicity diagnosed upon or after completing course of isoniazid.

^‡Acute psychosis attributed to alcohol withdrawal-associated delirium.

^§Causes of death: group 1—one participant with oesophageal cancer; group 3—one participant with haemorrhagic pancreatitis with pneumonia; one participant with active tuberculosis disease; one participant with sepsis; one participant died of unknown cause (participant had completed isoniazid).