TABLE 4.
Occurrence and severity of symptoms of intolerance assessed daily for 8 days by patients with tuberculosis randomized in a crossover study to receive either 4 g granular slow-release para-aminosalicylic acid twice daily or 8 g once daily in addition to a background regimen of other second-line antituberculosis agents
| Symptom | Result for GRS-PAS dosing regimena |
|||||
|---|---|---|---|---|---|---|
| 4 g twice daily |
8 g once daily |
|||||
| n | No. (%) with occurrence | Severity median (range) | n | No. (%) with occurrence (%) | Severity median (range) | |
| Abdominal pain and cramps | 30 | 18 (60) | 0.9 (0–10.0) | 31 | 10 (32) | 0 (0–8.1) |
| Nausea | 30 | 24 (80) | 1.3 (0–9.3) | 31 | 22 (71) | 1.4 (0–9.4) |
| Vomiting | 30 | 13 (43) | 0 (0–2.0) | 31 | 11 (35) | 0 (0–5.0) |
| Diarrhea | 30 | 21 (70) | 1.4 (0–10.0) | 31 | 21 (68) | 1.8 (0–9.4) |
| Bloated | 30 | 18 (60) | 0.8 (0–8.7) | 31 | 15 (48) | 0 (0–9.4) |
a
“Occurrence” refers to any reported experience of the symptom by a patient during any one of the 8 days of observation on each regimen. “Severity” (i.e., intensity) refers to the single highest visual analog score out of a possible score of 10 allotted by a patient to a particular symptom on any of the 8 days of observation on each regimen. For vomiting, intensity was counted as the number of times this occurred.