Table 3. Events during study.
| Characteristic# | All (N = 198) |
No IRIS (N = 160) |
IRIS present (N = 38) |
P value |
|---|---|---|---|---|
| During study | ||||
| Weeks on study (IQR) |
48 (28.5; 48) | 48 (24; 48) | 48 (45–49) | 0.165 |
| Commenced IPT | 3 (1.5%) | 2 (1.25%) | 1 (2.63%) | 0.7 |
| TB | ||||
| Began TB treatment | 15 (7.4%) | 6 (3.75%) | 9 (23.7%)§ | 0.0003* |
| TB IRIS | 6 (15.8%) | |||
| Other IRIS (including BCG) | 2 (5.3%) | 0.17 | ||
| Death | 9 (4.5%) | 6 (3.8%) | 3 (7.9%) | 0.378 |
| Non-IRIS infectious or inflammatory events from day 4 to day 17 | 40 (20.2%) | 24 (15.2%) | 14 (35%) | 0.0007* |
# 4 children lost to follow-up after baseline visit excluded
* Fisher’s exact two-tail test
§ 6 of 9 in IRIS group commencing anti-TB therapy had unmasking TB IRIS; 3 participants had non-TB IRIS events–oral candidiasis; BCG and oral candidiasis; and CMV colitis