Appendix Table 6.
All Reported AEs*
| Variable | Overall (n = 1002) | DOT (n = 337) | SAT (n = 337) | SAT With Reminders (n = 328) |
|---|---|---|---|---|
| All AEs | 208 | 64 | 72 | 72 |
|
| ||||
| Toxicity grade | ||||
| Grade 1 or 2 or not applicable | 118 | 38 | 42 | 38 |
|
| ||||
| Drug-related† | 47 | 16 | 19 | 12 |
|
| ||||
| Not drug-related‡ | 71 | 22 | 23 | 26 |
|
| ||||
| Grade 3 or 4 | 89 | 26 | 30 | 33 |
|
| ||||
| Drug-related† | 33 | 8 | 10 | 15 |
|
| ||||
| Not drug-related‡ | 56 | 18 | 20 | 18 |
|
| ||||
| Death (grade 5) | 1 | 0 | 0 | 1§ |
|
| ||||
| SAE|| | 29 | 14 | 9 | 6 |
|
| ||||
| Drug-related† | 5¶ | 3 | 0 | 2 |
|
| ||||
| Not drug-related‡ | 24 | 11 | 9 | 4 |
|
| ||||
| Attribution | ||||
| Drug-related† | 80 | 24 | 29 | 27 |
|
| ||||
| Not drug-related‡ | 128 | 40 | 43 | 45 |
|
| ||||
| AE of special interest | ||||
| Systemic drug reaction | 43 | 13 | 16 | 14 |
|
| ||||
| Hepatitis | 9 | 1 | 3 | 5 |
|
| ||||
| Isolated hepatitis | 4 | 0 | 1 | 3 |
|
| ||||
| Drug-related† | 2 | 0 | 1 | 1 |
|
| ||||
| Not drug-related‡ | 2 | 0 | 0 | 2 |
|
| ||||
| Hepatitis associated with systemic drug reaction | 5 | 1 | 2 | 2 |
|
| ||||
| Completed treatment | 1 | 1 | 0 | 0 |
|
| ||||
| Did not complete treatment | 4 | 0 | 2 | 2 |
|
| ||||
| Thrombocytopenia | 1** | 0 | 0 | 1 |
|
| ||||
| Neutropenia | 1** | 1 | 0 | 0 |
AE = adverse event; DOT = directly observed therapy; SAE = severe adverse event; SAT = self-administered therapy.
Values are numbers of AEs.
Considered to be definitely, probably, or possibly related to the study drugs.
Considered to be an unlikely relation to the study drugs, not related, or unclassifiable.
A 25-year-old patient born in South Africa with a social history of alcohol consumption, cigarette smoking, and unemployment committed suicide 5 d after the first study dose given by DOT. The patient had no history of psychiatric disorders or suicidal ideation and no signs of depression or anxiety before or after the first study dose.
Death, any life-threatening experience, any inpatient hospitalization or prolongation of any hospitalization, any persistently or severely disabling event, a congenital anomaly or birth defect, an overdose of study drugs, or any grade 4 toxicity event.
Four hospitalizations (1 patient in the DOT group and 1 patient in the SAT-with-reminders group had gastrointestinal symptoms, 1 patient in the DOT group had an event of rheumatoid arthritis related to a drug interaction, and 1 patient in the DOT group had a systemic drug reaction). One patient in the SAT-with-reminders group had grade 4 fatigue without hospitalization.
The only event of thrombocytopenia was considered to be related to the study drugs, whereas the only event of neutropenia was not considered to be related to the study drugs.