Table 3. Serious and severe adverse events detected by self-report and record review, by study arm.
| Intervention | Control | |||
|---|---|---|---|---|
| Number of events (# participants) | 29 (28) | 11 (10) | ||
|
| ||||
| Age in years, median (range) | 35 (22–52) | 39 (30–55) | ||
|
| ||||
| Sex, n (%) female | 14 (50%) | 4 (40%) | ||
|
| ||||
| CD4 at enrolment in cells per μL, median (range) | 68 (4–143) | 50·5 (21–142) | ||
|
| ||||
| Type, n (%) | Nausea/vomiting† | 10 (33%) | 4 (36%) | |
|
| ||||
| Suspected peripheral neuropathy | 8 (27%) | 2 (18%) | ||
|
| ||||
| Skin rash/hypersensitivity | 6 (20%) | 2 (18%) | ||
|
| ||||
| Abnormal liver function tests/hepatitis | 4 (13%) | 3 (27%) | ||
|
| ||||
| Other* | 1 (7%) | 0 | ||
|
| ||||
| Days from enrolment to onset of AE | Median; IQR range |
26; 13–79 0–169 |
29; 8–109 7–166 |
|
|
| ||||
| AE occurred after ART start‡, n (%) | At least one day after | 14 (48%) | 5 (45%) | |
| Before/same day as ART start | 12 (41%) | 3 (27%) | ||
| Did not start ART | 3 (10%) | 3 (27%) | ||
|
| ||||
| Days from starting ART to AE, restricted to AEs after ART | Median; range n |
53·5; 3–162 14 |
103; 18–144 5 |
|
|
| ||||
| AE occurred after TB start‡, n (%) | At least one day after | 19 (66%) | 5 (45%) | |
| Before/same day as TB start | 4 (14%) | 1 (9%) | ||
| Did not start TB treatment | 6 (21%) | 5 (45%) | ||
|
| ||||
| Days from starting TB treatment to AE, restricted to AEs after TB | Median; range n |
21; 1–165 19 |
14; 5–125 5 |
|
|
| ||||
| Outcome of AE, n (%) | Resolved | 15 (52%) | 8 (73%) | |
| Resolved with sequelae | 1 (3%) | 0 | ||
| Ongoing | 7 (24%) | 1 (9%) | ||
| Fatal† | 6 (21%) | 2 (18%) | ||
|
| ||||
| Relationship with intervention, n(%) | Not associated | 9 (31%) | 11 (100%) | |
| Probably not associated | 1 (3%) | 0 | ||
| Possibly associated | 7 (24%) | 0 | ||
| Probably associated | 8 (28%) | 0 | ||
| Definitely associated† | 4 (14%) | 0 | ||
generalised body weakness
One adverse event of nausea/vomiting (see appendix page 7: AE5) is recorded as definitely associated with a fatal outcome because there was no documentation of resolution. The patient was lost to follow-up from TB treatment, subsequently admitted to hospital with vomiting and diarrhoea and died 48 days post-enrolment. Hospital-assigned cause of death was meningitis and renal failure. Autopsy: Mycobacterium tuberculosis (sensitive to isoniazid and rifampicin) isolated from liver and spleen but not cerebrospinal fluid. Panel-assigned cause of death was disseminated TB. Therefore, the adverse event (nausea and vomiting) was considered associated, but death was considered not associated with the intervention.
33/38 participants started ART (8/10 in control arm and 25/28 in intervention arm); 28/38 started TB treatment (5/10 in control arm and 23/28 in intervention arm).
Two participants reported two AEs each; one in the control arm – both events (abnormal liver function tests/hepatitis and nausea/vomiting) occurred 5 days after starting TB treatment (patient did not start ART); one in the intervention arm - nausea/vomiting occurred on the same day as starting ART and suspected peripheral neuropathy occurred after starting ART (patient did not start TB treatment).
AE=adverse event. IQR=interquartile range. ART=antiretroviral therapy. TB=tuberculosis.