Table 3.
Main type of clinical symptoms before treatment and adverse events 3 h and 24 h after praziquantel administration in SAC (n=177) and PSAC (n=124)
|
Preschool-aged children (PSAC) |
School-aged children (SAC) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=27*) | Praziquantel 20 mg/kg (n=35*) | Praziquantel 40 mg/kg (n=29*) | Praziquantel 60 mg/kg (n=33*) | Overall (n=124) | Placebo (n=42) | Praziquantel 20 mg/kg (n=47) | Praziquantel 40 mg/kg (n=46) | Praziquantel 60 mg/kg (n=42) | Overall (n=177) | |
| Before treatment | ||||||||||
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mild | 19 (70%) | 21 (60%) | 17 (59%) | 21 (64%) | 78 (63%) | 22 (52%) | 29 (62%) | 28 (61%) | 25 (60%) | 104 (59%) |
| None | 8 (30%) | 14 (40%) | 12 (41%) | 12 (36%) | 46 (37%) | 20 (48%) | 18 (38%) | 18 (39%) | 17 (40%) | 73 (41%) |
| Stomach ache | 3 (11%) | 3 (9%) | 8 (28%) | 4 (12%) | 18 (15%) | 12 (29%) | 6 (13%) | 10 (22%) | 8 (19%) | 36 (20%) |
| Cough | 9 (33%) | 11 (31%) | 10 (35%) | 6 (18%) | 36 (2%9) | 10 (24%) | 22 (47%) | 20 (43%) | 14 (33%) | 66 (37%) |
| Diarrhoea | 6 (22%) | 6 (17%) | 4 (14%) | 5 (15%) | 21 (17%) | 4 (10%) | 2 (4%) | 7 (15%) | 0 | 13 (7%) |
| Headache | 0 | 2 (6%) | 0 | 1 (3%) | 3 (2%) | 5 (12%) | 5 (11%) | 1 (2%) | 6 (14%) | 17 (10%) |
| Vomiting | 2 (7%) | 0 | 3 (10%) | 1 (3%) | 6 (5%) | 2 (5%) | 2 (4%) | 1 (2%) | 2 (5%) | 7 (4%) |
| Itching | 2 (7%) | 2 (6%) | 2 (7%) | 4 (12%) | 10 (8%) | 1 (2%) | 3 (6%) | 2 (4%) | 1 (2%) | 7 (4%) |
| Fever | 3 (11%) | 7 (20%) | 7 (24%) | 11 (33%) | 28 (23%) | 0 | 0 | 1 (2%) | 2 (5%) | 3 (2%) |
| 3 h post treatment | ||||||||||
| Moderate | 0 | 1 (3%) | 2 (7%) | 0 | 3 (2%) | 1 (2%) | 0 | 0 | 1 (2%) | 2 (1%) |
| Mild | 3 (11%) | 7 (20%) | 8 (28%) | 11 (33%) | 29 (23%) | 20 (48%) | 36 (77%) | 36 (78%) | 32 (76%) | 124 (70%) |
| None | 24 (89%) | 27 (77%) | 19 (66%) | 22 (67%) | 92 (74%) | 21 (50%) | 11 (23%) | 10 (22%) | 9 (21%) | 51 (29%) |
| Stomach ache | 0 | 1 (3%) | 5 (17%) | 4 (12%) | 10 (8%) | 11 (26%) | 22 (47%) | 17 (37%) | 16 (38%) | 66 (37%) |
| Cough | 0 | 2 (6%) | 2 (7%) | 2 (6%) | 6 (5%) | 3 (7%) | 8 (17%) | 4 (9%) | 9 (21%) | 24 (14%) |
| Diarrhoea | 1 (4%) | 5 (14%) | 2 (7%) | 3 (9%) | 11 (9%) | 5 (12%) | 12 (26%) | 17 (37%) | 16 (38%) | 50 (28%) |
| Headache | 1 (4%) | 1 (3%) | 1 (3%) | 0 | 3 (2%) | 4 (10%) | 7 (15%) | 5 (11%) | 11 (26%) | 27 (15%) |
| Vomiting | 0 | 1 (3%) | 1 (3%) | 2 (6%) | 4 (3%) | 2 (5%) | 7 (15%) | 9 (20%) | 8 (19%) | 26 (15%) |
| Itching | 0 | 0 | 0 | 0 | 0 | 1 (2%) | 3 (6%) | 2 (4%) | 1 (2%) | 7 (4%) |
| Fever | 1 (4%) | 1 (3%) | 0 | 0 | 2 (2%) | 2 (5%) | 2 (4%) | 0 | 1 (2%) | 5 (3%) |
| 24 h post treatment | ||||||||||
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Mild | 4 (15%) | 5 (14%) | 1 (3%) | 6 (18%) | 16 (13%) | 16 (38%) | 17 (36%) | 18 (39%) | 16 (38%) | 67 (38%) |
| None | 23 (85%) | 30 (86%) | 28 (97%) | 27 (82%) | 108 (87%) | 26 (62%) | 30 (64%) | 28 (61%) | 26 (62%) | 110 (62%) |
| Stomach ache | 0 | 0 | 0 | 0 | 0 | 7 (17%) | 9 (19%) | 4 (9%) | 8 (19%) | 28 (16%) |
| Cough | 0 | 0 | 0 | 2 (6%) | 0 | 5 (12%) | 5 (11%) | 5 (11%) | 5 (12%) | 20 (11%) |
| Diarrhoea | 0 | 5 (14%) | 0 | 1 (3%) | 6 (5%) | 5 (12%) | 4 (9%) | 3 (7%) | 6 (14%) | 18 (10%) |
| Headache | 1 (4%) | 0 | 1 (3%) | 1 (3%) | 3 (2%) | 2 (5%) | 2 (4%) | 3 (7%) | 4 (10%) | 11 (6%) |
| Vomiting | 2 (7%) | 1 (3%) | 0 | 1 (3%) | 4 (3%) | 2 (5%) | 2 (4%) | 3 (7%) | 4 (10%) | 11 (6%) |
| Itching | 0 | 0 | 0 | 1 (3%) | 0 | 4 (10%) | 3 (6%) | 3 (7%) | 3 (7%) | 13 (7%) |
| Fever | 1 (4%) | 0 | 0 | 1 (3%) | 2 (2%) | 1 (2%) | 0 | 0 | 0 | 1 (1%) |
Data are n (%).
*
30 kids were absent (placebo [n=9], 20 mg/kg [n=5], 40 mg/kg [n=9], and 60 mg/kg [n=7]) following treatment and were not assessed for adverse events.