Severe adverse events
| . | IVIg (n = 100) . | Observation (n = 100) . |
|---|---|---|
| Bleeding events | n = 1 | n = 13 |
| Grade 2/3 bleeding, observation only | 0 | 5 |
| Grade 3 bleeding, treatment instituted* | 1 | 3† |
| Grade 4/5 bleeding, necessitating treatment | 1‡ | 10¶ |
| Adverse reactions treatment | n = 5 | n = 0 |
| Allergic reactions | 1 | 0 |
| Other (nausea, vomiting, headache) | 4 | 0 |
| Other severe adverse events | n = 4 | n = 6 |
| Observation after mild traumatic head injury | 3 | 7§ |
| Infections | 1 | 3‖ |
| . | IVIg (n = 100) . | Observation (n = 100) . |
|---|---|---|
| Bleeding events | n = 1 | n = 13 |
| Grade 2/3 bleeding, observation only | 0 | 5 |
| Grade 3 bleeding, treatment instituted* | 1 | 3† |
| Grade 4/5 bleeding, necessitating treatment | 1‡ | 10¶ |
| Adverse reactions treatment | n = 5 | n = 0 |
| Allergic reactions | 1 | 0 |
| Other (nausea, vomiting, headache) | 4 | 0 |
| Other severe adverse events | n = 4 | n = 6 |
| Observation after mild traumatic head injury | 3 | 7§ |
| Infections | 1 | 3‖ |
Severe adverse events included events that occurred from the day of enrollment until the last study visit at 12 months.
The numbers in gray rows are numbers of patients; the numbers in white rows are numbers of reported events. A patient could have more than 1 event, and each patient could be counted in more than 1 category.
Treatment not mandatory but based on wish of parents or patients/decision of treating pediatrician.
One patient is also listed in this table for clinical observation because of grade 3 bleeding.
This patient was also treated with methylprednisolone for grade 3 bleeding, as listed in this table.
Two times in 1 patient; 3 other patients in this group are also listed for grade 2/3 bleeding for which clinical observation was instituted.
Four times in 1 patient.
Two times in 1 patient.