TABLE 2.
Grade 1 and 2 adverse events, stratified by treatment arma
| Eventd | Value for the group |
|||
|---|---|---|---|---|
| NTZ single-drug therapy (n = 20) |
Standard four-drug therapy (n = 10)b |
|||
| No. (%) of participants | No. of eventsc | No. (%) of participants | No. of eventsc | |
| Abdominal paine | 17 (85) | 43 | 7 (70) | 13 |
| Nausea | 15 (75) | 30 | 8 (80) | 21 |
| Vomiting | 14 (70) | 33 | 6 (60) | 11 |
| Diarrhea | 8 (40) | 19 | 4 (40) | 7 |
| Headache | 9 (45) | 17 | 5 (50) | 13 |
| Skin pruritus | 1 (5) | 1 | 0 (0) | 0 |
| Elevated AST | 2 (10) | 2 | 1 (10) | 1 |
| Elevated ALT | 3 (15) | 3 | 0 (0) | 0 |
| Elevated alkaline phosphatase | 5 (25) | 6 | 0 (0) | 0 |
| Otherf | 9 (45) | 10 | 1 (10) | 1 |
| Total | 20 (100) | 164 | 10 (100) | 67 |
There was one grade 3 adverse event (rash) related to NTZ. There were no grade 4 events related to NTZ. There were no grade 3 or 4 adverse events related to standard therapy.
Therapy with isoniazid, rifampin, ethambutol, and pyrazinamide (HREZ).
Events are unique episodes of the described symptom. Participants may have had more than one event of the same symptom.
AST, aspartate aminotransferase; ALT, alanine aminotransferase.
The incidence rate of abdominal pain in the NTZ single-drug treatment group was 1.72 times greater than that in the standard four-drug treatment group using Poisson regression (P = 0.084).
Arthralgia, anorexia, hypoglycemia, hyperglycemia, loose stool, myalgia, palpitation, polyarthralgia, or scleral icterus.