Frequency of Pretreatment Symptoms and Adverse Events as Experienced by Children According to Treatment Arms in the Per Protocol Population
| Symptoms . | Placebo . | 100 mg . | 200 mg . | 400 mg . | Overall . |
|---|---|---|---|---|---|
| 33 . | 32 . | 30 . | 32 . | (n = 127a) . | |
| Before treatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mild | 11 (33.3) | 15 (46.9) | 7 (23.3) | 9 (28.1) | 42 (30.1) |
| None | 22 (66.7) | 17 (53.1) | 23 (76.7) | 23 (71.9) | 85 (66.9) |
| Headache | 6 (18.2) | 5 (15.6) | 1 (3.3) | 4 (12.5) | 16 (12.6) |
| Stomach ache | 5 (15.2) | 4 (12.5) | 3 (10.0) | 3 (9.4) | 15 (11.8) |
| Itching | 3 (9.1) | 4 (12.5) | 3 (10.0) | 2 (6.3) | 12 (9.4) |
| Thrill | 0 (0.0) | 5 (15.6) | 2 | 4 (12.5) | 11 (8.7) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 0 (0.0) | 1 (0.8) |
| Vomiting | 0 (0.0) | 1 (3.1) | 1 (3.3) | 0 (0.0) | 2 (1.6) |
| Diarrhea | 2 (6.1) | 1 (3.1) | 3 (10.0) | 0 (0.0) | 6 (4.7) |
| 3 h posttreatment | |||||
| Moderate | 0 (0.0) | 1 (3.1) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Mild | 9 (27.3) | 13 (40.6) | 9 (30.0) | 10 (31.3) | 41(32.3) |
| None | 24 (72.7) | 18 (56.3) | 21 (70.0) | 22 (68.8) | 85 (66.9) |
| Headache | 2 (6.1) | 4 (12.5) | 4 (13.3) | 2 (6.3) | 12 (9.4) |
| Stomach ache | 4 (12.1) | 5 (15.6) | 1 (3.3) | 6 (18.8) | 16 (12.6) |
| Itching | 1 (3.0) | 2 (6.3) | 2 (6.7) | 1 (3.1) | 6 (4.7) |
| Thrill | 3 (9.1) | 6 (18.8) | 6 (20.0) | 3 (9.4) | 18 (14.2) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Vomiting | 1 (3.0) | 0 (0.0) | 1 (3.3) | 2 (6.3) | 4 (3.1) |
| Diarrhea | 2 (6.1) | 2 (6.3) | 2 (6.7) | 4 (12.5) | 10 (7.9) |
| 24 h posttreatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Mild | 1 (3.0) | 3 (9.4) | 3 (10.0) | 2 (6.3) | 9 (7.1) |
| None | 32 (97.0) | 29 (90.6) | 27 (90.0) | 29 (90.6) | 117 (92.1) |
| Headache | 1 (3.0) | 3 (9.4) | 1 (3.3) | 1 (3.1) | 6 (4.7) |
| Stomach ache | 1 (3.0) | 2 (6.3) | 1 (3.3) | 0 (0.0) | 4 (3.1) |
| Itching | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Thrill | 1 (3.0) | 1 (3.1) | 0 (0.0) | 1 (3.1) | 3 (2.4) |
| Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Symptoms . | Placebo . | 100 mg . | 200 mg . | 400 mg . | Overall . |
|---|---|---|---|---|---|
| 33 . | 32 . | 30 . | 32 . | (n = 127a) . | |
| Before treatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mild | 11 (33.3) | 15 (46.9) | 7 (23.3) | 9 (28.1) | 42 (30.1) |
| None | 22 (66.7) | 17 (53.1) | 23 (76.7) | 23 (71.9) | 85 (66.9) |
| Headache | 6 (18.2) | 5 (15.6) | 1 (3.3) | 4 (12.5) | 16 (12.6) |
| Stomach ache | 5 (15.2) | 4 (12.5) | 3 (10.0) | 3 (9.4) | 15 (11.8) |
| Itching | 3 (9.1) | 4 (12.5) | 3 (10.0) | 2 (6.3) | 12 (9.4) |
| Thrill | 0 (0.0) | 5 (15.6) | 2 | 4 (12.5) | 11 (8.7) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 0 (0.0) | 1 (0.8) |
| Vomiting | 0 (0.0) | 1 (3.1) | 1 (3.3) | 0 (0.0) | 2 (1.6) |
| Diarrhea | 2 (6.1) | 1 (3.1) | 3 (10.0) | 0 (0.0) | 6 (4.7) |
| 3 h posttreatment | |||||
| Moderate | 0 (0.0) | 1 (3.1) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Mild | 9 (27.3) | 13 (40.6) | 9 (30.0) | 10 (31.3) | 41(32.3) |
| None | 24 (72.7) | 18 (56.3) | 21 (70.0) | 22 (68.8) | 85 (66.9) |
| Headache | 2 (6.1) | 4 (12.5) | 4 (13.3) | 2 (6.3) | 12 (9.4) |
| Stomach ache | 4 (12.1) | 5 (15.6) | 1 (3.3) | 6 (18.8) | 16 (12.6) |
| Itching | 1 (3.0) | 2 (6.3) | 2 (6.7) | 1 (3.1) | 6 (4.7) |
| Thrill | 3 (9.1) | 6 (18.8) | 6 (20.0) | 3 (9.4) | 18 (14.2) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Vomiting | 1 (3.0) | 0 (0.0) | 1 (3.3) | 2 (6.3) | 4 (3.1) |
| Diarrhea | 2 (6.1) | 2 (6.3) | 2 (6.7) | 4 (12.5) | 10 (7.9) |
| 24 h posttreatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Mild | 1 (3.0) | 3 (9.4) | 3 (10.0) | 2 (6.3) | 9 (7.1) |
| None | 32 (97.0) | 29 (90.6) | 27 (90.0) | 29 (90.6) | 117 (92.1) |
| Headache | 1 (3.0) | 3 (9.4) | 1 (3.3) | 1 (3.1) | 6 (4.7) |
| Stomach ache | 1 (3.0) | 2 (6.3) | 1 (3.3) | 0 (0.0) | 4 (3.1) |
| Itching | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Thrill | 1 (3.0) | 1 (3.1) | 0 (0.0) | 1 (3.1) | 3 (2.4) |
| Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
aThree children absent for adverse event examination are excluded.
Frequency of Pretreatment Symptoms and Adverse Events as Experienced by Children According to Treatment Arms in the Per Protocol Population
| Symptoms . | Placebo . | 100 mg . | 200 mg . | 400 mg . | Overall . |
|---|---|---|---|---|---|
| 33 . | 32 . | 30 . | 32 . | (n = 127a) . | |
| Before treatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mild | 11 (33.3) | 15 (46.9) | 7 (23.3) | 9 (28.1) | 42 (30.1) |
| None | 22 (66.7) | 17 (53.1) | 23 (76.7) | 23 (71.9) | 85 (66.9) |
| Headache | 6 (18.2) | 5 (15.6) | 1 (3.3) | 4 (12.5) | 16 (12.6) |
| Stomach ache | 5 (15.2) | 4 (12.5) | 3 (10.0) | 3 (9.4) | 15 (11.8) |
| Itching | 3 (9.1) | 4 (12.5) | 3 (10.0) | 2 (6.3) | 12 (9.4) |
| Thrill | 0 (0.0) | 5 (15.6) | 2 | 4 (12.5) | 11 (8.7) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 0 (0.0) | 1 (0.8) |
| Vomiting | 0 (0.0) | 1 (3.1) | 1 (3.3) | 0 (0.0) | 2 (1.6) |
| Diarrhea | 2 (6.1) | 1 (3.1) | 3 (10.0) | 0 (0.0) | 6 (4.7) |
| 3 h posttreatment | |||||
| Moderate | 0 (0.0) | 1 (3.1) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Mild | 9 (27.3) | 13 (40.6) | 9 (30.0) | 10 (31.3) | 41(32.3) |
| None | 24 (72.7) | 18 (56.3) | 21 (70.0) | 22 (68.8) | 85 (66.9) |
| Headache | 2 (6.1) | 4 (12.5) | 4 (13.3) | 2 (6.3) | 12 (9.4) |
| Stomach ache | 4 (12.1) | 5 (15.6) | 1 (3.3) | 6 (18.8) | 16 (12.6) |
| Itching | 1 (3.0) | 2 (6.3) | 2 (6.7) | 1 (3.1) | 6 (4.7) |
| Thrill | 3 (9.1) | 6 (18.8) | 6 (20.0) | 3 (9.4) | 18 (14.2) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Vomiting | 1 (3.0) | 0 (0.0) | 1 (3.3) | 2 (6.3) | 4 (3.1) |
| Diarrhea | 2 (6.1) | 2 (6.3) | 2 (6.7) | 4 (12.5) | 10 (7.9) |
| 24 h posttreatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Mild | 1 (3.0) | 3 (9.4) | 3 (10.0) | 2 (6.3) | 9 (7.1) |
| None | 32 (97.0) | 29 (90.6) | 27 (90.0) | 29 (90.6) | 117 (92.1) |
| Headache | 1 (3.0) | 3 (9.4) | 1 (3.3) | 1 (3.1) | 6 (4.7) |
| Stomach ache | 1 (3.0) | 2 (6.3) | 1 (3.3) | 0 (0.0) | 4 (3.1) |
| Itching | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Thrill | 1 (3.0) | 1 (3.1) | 0 (0.0) | 1 (3.1) | 3 (2.4) |
| Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Symptoms . | Placebo . | 100 mg . | 200 mg . | 400 mg . | Overall . |
|---|---|---|---|---|---|
| 33 . | 32 . | 30 . | 32 . | (n = 127a) . | |
| Before treatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mild | 11 (33.3) | 15 (46.9) | 7 (23.3) | 9 (28.1) | 42 (30.1) |
| None | 22 (66.7) | 17 (53.1) | 23 (76.7) | 23 (71.9) | 85 (66.9) |
| Headache | 6 (18.2) | 5 (15.6) | 1 (3.3) | 4 (12.5) | 16 (12.6) |
| Stomach ache | 5 (15.2) | 4 (12.5) | 3 (10.0) | 3 (9.4) | 15 (11.8) |
| Itching | 3 (9.1) | 4 (12.5) | 3 (10.0) | 2 (6.3) | 12 (9.4) |
| Thrill | 0 (0.0) | 5 (15.6) | 2 | 4 (12.5) | 11 (8.7) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 0 (0.0) | 1 (0.8) |
| Vomiting | 0 (0.0) | 1 (3.1) | 1 (3.3) | 0 (0.0) | 2 (1.6) |
| Diarrhea | 2 (6.1) | 1 (3.1) | 3 (10.0) | 0 (0.0) | 6 (4.7) |
| 3 h posttreatment | |||||
| Moderate | 0 (0.0) | 1 (3.1) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Mild | 9 (27.3) | 13 (40.6) | 9 (30.0) | 10 (31.3) | 41(32.3) |
| None | 24 (72.7) | 18 (56.3) | 21 (70.0) | 22 (68.8) | 85 (66.9) |
| Headache | 2 (6.1) | 4 (12.5) | 4 (13.3) | 2 (6.3) | 12 (9.4) |
| Stomach ache | 4 (12.1) | 5 (15.6) | 1 (3.3) | 6 (18.8) | 16 (12.6) |
| Itching | 1 (3.0) | 2 (6.3) | 2 (6.7) | 1 (3.1) | 6 (4.7) |
| Thrill | 3 (9.1) | 6 (18.8) | 6 (20.0) | 3 (9.4) | 18 (14.2) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Vomiting | 1 (3.0) | 0 (0.0) | 1 (3.3) | 2 (6.3) | 4 (3.1) |
| Diarrhea | 2 (6.1) | 2 (6.3) | 2 (6.7) | 4 (12.5) | 10 (7.9) |
| 24 h posttreatment | |||||
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Mild | 1 (3.0) | 3 (9.4) | 3 (10.0) | 2 (6.3) | 9 (7.1) |
| None | 32 (97.0) | 29 (90.6) | 27 (90.0) | 29 (90.6) | 117 (92.1) |
| Headache | 1 (3.0) | 3 (9.4) | 1 (3.3) | 1 (3.1) | 6 (4.7) |
| Stomach ache | 1 (3.0) | 2 (6.3) | 1 (3.3) | 0 (0.0) | 4 (3.1) |
| Itching | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.1) | 1 (0.8) |
| Thrill | 1 (3.0) | 1 (3.1) | 0 (0.0) | 1 (3.1) | 3 (2.4) |
| Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Vomiting | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (3.1) | 2 (1.6) |
| Diarrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
aThree children absent for adverse event examination are excluded.
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