Table 2.
Research cohort database (n = 559) |
Routine clinic database (n = 559) |
Routine clinic database (n = 1233) |
% underreporting of OI events in 559 patients in routine clinic vs. research cohort database (Comparison A) |
% underreporting of OI events in 1233 patients in routine clinic vs. research cohort database (Comparison B) |
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Type of OI | No. of OI events |
Incidence rate (95% CI (per 100 PYAR) | No. of OI events |
Incidence rate (95% CI (per 100 PYAR) | No. of OI events |
Incidence rate (95% CI (per 100 PYAR) | Based on absolute number of OI events | Based on OI rates |
Based on OI rates |
Overall (initial OI only) | 154a | 24.1 (20.5- 28.2) | 91a | 13.2 (10.8 - 16.2) | 206a | 10.4 (9.1 - 11.9) | 40.9 | 45.2 | 56.8 |
Oral candidiasis | 63 | 8.4 (6.5 - 10.7) | 26 | 3.7 (2.5 - 5.4) | 54 | 2.6 (2.0 - 3.3) | 58.7 | 55.9 | 69.0 |
Severe bacterial pneumonia | 44 | 5.5 (4.1 - 7.6) | 8 | 1.0 (0.5 - 2.1) | 4 | 0.2 (0.1 - 0.5) | 81.8 | 81.8 | 96.4 |
Tuberculosis | 33 | 4.1 (2.9 - 5.8) | 27 | 3.6 (2.5 - 5.3) | 73 | 3.6 (2.8 - 4.5) | 18.2 | 12.2 | 12.2 |
Herpes zoster | 29 | 3.6 (2.5 - 5.2) | 5 | 0.6 (0.3 - 1.3) | 9 | 0.4 (0.2 - 0.8) | 82.7 | 83.3 | 88.8 |
Cryptococcus meningitis | 7 | 0.8 (0.4 - 1.8) | 7 | 0.9 (0.4 - 1.9) | 16 | 0.7 (0.4 - 1.2) | 0 | +12.5 b | 12.5 |
Genital herpes | 5 | 0.6 (0.2 - 1.4) | 15 | 2.0 (1.2 - 3.3) | 12 | 0.5 (0.3 - 1.0) | +200 b | +233b | 16.7 |
Kaposi's sarcoma | 5 | 0.6 (0.2 - 1.4) | 5 | 0.6 (0.3 - 1.6) | 31 | 1.5 (1.1 - 2.2) | 0 | +16.7 b | +150 b |
Oesophageal candidiasis | 5 | 0.6 (0.2 - 1.4) | 0 | 0.0 (0.0 - 0.0) | 4 | 0.2 (0.1 - 0.5) | 100 | 100 | 66.7 |
Cerebral toxoplasmosis | 2 | 0.2 (0.1 - 0.9) | 0 | 0.0 (0.0 - 0.0) | 4 | 0.2 (0.1 - 0.5) | 100 | 100 | 0 |
Other OIsc | 8 | 0.9 (0.5 - 1.9) | 3 | 0.4 (0.1 - 1.2) | 11 | 0.5 (0.3 - 0.9) | 62.5 | 55.5 | 44.4 |
a represents the total number of initial OI events only. In the research cohort database of 559 patients, there were 154 initial OIs, but a total of 204 events, as 116 had one OI, 28 had two OI events, and 10 had three or more OIs. In routine clinic database of 559 patients, there were 91 initial OIs, but at total of 100 events, as 87 had one OI, seven had two OI events, and one patient had three OIs. In routine clinic database of 1233 patients, there were 206 initial OIs, but a total of 224 events, as 188 had one OI, 16 had two OI events, and two patients had three OIs.)
b OIs where there were more events reported in the clinic versus research database, representing underreporting in the research database.
c Other OIs includes Pneumocystis jirovecii pneumonia, CMV retinitis, lymphoma, HIV-related anaemia, septicaemia, chronic diarrhoea, intracerebral mass, and pulmonary aspergillosis.