Preschool-aged children (PSAC)a | School-aged children (SAC)b | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Symptoms | Placebo | 20 mg/kg | 40 mg/kg | 60 mg/kg | Overall | Placebo | 20 mg/kg | 40 mg/kg | 60 mg/kg | Overall |
(n = 41) | (n = 40) | (n = 44) | (n = 43) | (n = 168) | (n = 38) | (n = 45) | (n = 46) | (n = 44) | (n = 173) | |
Before treatment | ||||||||||
Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Mild | 24 (58.5) | 19 (47.5) | 26 (59.1) | 19 (44.2) | 88 (52.4) | 20 (52.6) | 26 (57.8) | 25 (54.3) | 21 (47.7) | 92 (53.2) |
None | 17 (41.5) | 21 (52.5) | 18 (40.9) | 24 (55.8) | 80 (47.6) | 18 (47.4) | 19 (42.2) | 21 (45.7) | 23 (52.3) | 81 (46.8) |
Fever | 6 (14.1) | 3 (7.5) | 7 (15.9) | 5 (11.6) | 21 (12.5) | 5 (13.2) | 7 (15.6) | 5 (10.9) | 6 (13.6) | 23 (13.3) |
Headache | 8 (19.5) | 6 (15.0) | 13 (29.5) | 10 (23.3) | 37 (22.0) | 3 (7.9) | 7 (15.6) | 10 (21.7) | 7 (15.9) | 27 (15.6) |
Nausea | 3 (7.3) | 4 (10.0) | 3 (6.8) | 1 (2.3) | 11 (6.5) | 2 (5.3) | 1 (2.2) | 4 (8.7) | 5 (11.4) | 12 (6.9) |
Vomiting | 1 (2.4) | 1 (2.5) | 1 (2.3) | 2 (4.7) | 5 (3.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 1 (0.6) |
Diarrhoea | 4 (9.6) | 4 (10.0) | 4 (9.1) | 5 (11.6) | 17 (10.1) | 0 (0.0) | 1 (2.2) | 3 (6.5) | 2 (4.5) | 6 (3.5) |
Dizziness | 2 (4.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Stomach ache | 2 (4.9) | 5 (12.5) | 8 (18.2) | 4 (9.3) | 19 (11.3) | 1 (2.6) | 6 (13.3) | 6 (13.0) | 4 (9.1) | 17 (9.8) |
3 h post-treatment | ||||||||||
Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.3) | 1 (0.6) | 1 (2.6) | 2 (4.4) | 4 (8.7) | 5 (11.4) | 12 (6.9) |
Mild | 6 (14.6) | 8 (20.0) | 15 (34.1) | 23 (53.5) | 52 (31.0) | 18 (47.4) | 23 (51.1) | 21 (45.7) | 26 (59.1) | 88 (50.9) |
None | 35 (85.4) | 32 (80.0) | 29 (65.9) | 19 (44.2) | 115 (68.5) | 19 (50.0) | 20 (44.4) | 21 (45.7) | 13 (29.5) | 73 (42.2) |
Fever | 3 (7.3) | 3 (7.5) | 2 (4.5) | 4 (9.3) | 12 (7.1) | 6 (15.8) | 4 (8.9) | 8 (17.4) | 12 (27.3) | 30 (17.3) |
Headache | 1 (2.4) | 2 (5.0) | 1 (2.3) | 7 (16.3) | 11 (6.5) | 8 (21.1) | 10 (22.2) | 6 (13.0) | 6 (13.6) | 30 (17.3) |
Nausea | 1 (2.4) | 1 (2.5) | 4 (9.1) | 5 (11.6) | 11 (6.5) | 4 (10.5) | 3 (6.7) | 9 (19.6) | 14 (31.8) | 30 (17.3) |
Vomiting | 0 (0.0) | 1 (2.5) | 3 (6.8) | 9 (20.9) | 13 (7.7) | 1 (2.6) | 3 (6.7) | 8 (17.4) | 10 (22.7) | 22 (12.7) |
Diarrhoea | 0 (0.0) | 1 (2.5) | 1 (2.3) | 3 (7.0) | 5 (3.0) | 3 (7.9) | 3 (6.7) | 2 (4.3) | 0 (0.0) | 8 (4.6) |
Dizziness | 1 (2.4) | 1 (2.5) | 2 (4.5) | 4 (9.3) | 8 (4.8) | 5 (13.2) | 4 (8.9) | 8 (17.4) | 5 (11.4) | 22 (12.7) |
Stomach ache | 3 (7.3) | 4 (10.0) | 4 (9.1) | 2 (4.7) | 13 (7.7) | 5 (13.2) | 11 (24.4) | 9 (19.6) | 12 (27.3) | 37 (21.4) |
24 h post-treatment | ||||||||||
Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Mild | 4 (9.6) | 7 (17.5) | 8 (18.2) | 6 (14.0) | 25 (14.9) | 12 (31.6) | 12 (26.7) | 12 (26.1) | 11 (25.0) | 47 (27.2) |
None | 37 (90.2) | 33 (82.5) | 36 (81.8) | 37 (86.0) | 143 (85.1) | 26 (68.4) | 33 (73.3) | 34 (73.9) | 33 (75.0) | 126 (72.8) |
Fever | 2 (4.9) | 4 (10.0) | 2 (4.5) | 2 (4.7) | 10 (6.0) | 5 (13.2) | 7 (15.6) | 5 (10.9) | 6 (13.6) | 23 (13.3) |
Headache | 1 (2.4) | 1 (2.5) | 1 (2.3) | 2 (4.7) | 5 (3.0) | 3 (7.9) | 7 (15.6) | 10 (21.7) | 7 (15.9) | 27 (15.6) |
Nausea | 1 (2.4) | 0 (0.0) | 0 (0.0) | 3 (7.0) | 4 (2.4) | 2 (5.3) | 1 (2.2) | 4 (8.7) | 5 (11.4) | 12 (6.9) |
Vomiting | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (7.0) | 3 (1.8) | 0 (0.0) | 0 (0.0) | 1 (2.2) | 0 (0.0) | 1 (0.6) |
Diarrhoea | 1 (2.4) | 2 (5.0) | 5 (11.4) | 0 (0.0) | 8 (4.8) | 0 (0.0) | 1 (2.2) | 3 (6.5) | 2 (4.5) | 6 (3.5) |
Dizziness | 1 (2.4) | 0 (0.0) | 0 (0.0) | 1 (2.3) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Stomach ache | 2 (4.9) | 0 (0.0) | 2 (4.5) | 2 (4.7) | 6 (3.6) | 1 (2.6) | 6 (13.3) | 6 (13.0) | 4 (9.1) | 17 (9.8) |