Table 3.
Adverse events. Data are number (%) of participants or mean (standard deviation)
| Antibiotic prophylaxis (n=142*) | Methenamine hippurate (n=127*) | |
|---|---|---|
| No of adverse events reported per participant | 1.9 (2.8) | 1.8 (2.4) |
| Worst grade adverse event reported per participant | ||
| None | 59 (42) | 45 (35) |
| Mild | 41 (29) | 47 (37) |
| Moderate | 34 (24) | 29 (23) |
| Severe | 8 (6) | 6 (5) |
| No of adverse reactions reported per participant | 0.4 (0.7) | 0.4 (0.7) |
| No of participants reporting an adverse reaction | 34 (24) | 35 (28) |
| Worst grade adverse reaction reported per participant | ||
| None | 108 (76) | 92 (72) |
| Mild | 24 (17) | 26 (20) |
| Moderate | 9 (6) | 9 (7) |
| Severe | 1 (1) | 0 |
| No of participants affected by each adverse event† | ||
| Lower respiratory tract infection | 10 (7) | 9 (7) |
| Nausea | 12 (8) | 5 (4) |
| Abdominal pain | 7 (5) | 9 (7) |
| Diarrhoea | 8 (6) | 4 (3) |
| Alanine aminotransferase increased | 5 (4) | 5 (4) |
| Back pain | 7 (5) | 3 (2) |
| Headache | 3 (2) | 7 (6) |
| Candida infection | 4 (3) | 5 (4) |
| Dyspepsia | 5 (4) | 4 (3) |
| Rash | 3 (2) | 5 (4) |
| Abdominal discomfort | 3 (2) | 4 (3) |
| Dyspnoea | 5 (4) | 2 (2) |
| Fall | 3 (2) | 4 (3) |
| Vomiting | 3 (2) | 4 (3) |
| Depressed mood | 1 (1) | 4 (3) |
| Herpes zoster | 5 (4) | 0 |
*
Numbers of participants receiving each treatment.
†
Only those events occurring in at least 3% of participants in either group are reported.