Table 3 Latency and duration of the related TEAEs of headache, nausea, vomiting and fever stratified by severity (first period)
TEAE | Latency (days)a | Duration (days)b | ||||||
|---|---|---|---|---|---|---|---|---|
IVIg (n = 52) | Placebo (n = 48) | IVIg (n = 52) | Placebo (n = 48) | |||||
N | Median (range) | N | Median (range) | N | Median (range) | N | Median (range) | |
Headache | ||||||||
Mild | 32 | 0.5 (0.0–4.0) | 3 | 0.0 (0.0–14.0) | 32 | 1.0 (1.0–5.0) | 2 | 8.0 (1.0–15.0) |
Moderate | 12 | 2.0 (0.0–4.0) | 4 | 0.0 (0.0–0.0) | 12 | 2.5 (1.0–11.0) | 4 | 1.0 (1.0–2.0) |
Severe | 1 | 2.1 (2.1–2.1) | 0 | - | 1 | 3.0 (3.0–3.0) | 0 | - |
All | 45 | 1.0 (0.0–4.0) | 7 | 0.0 (0.0–14.0) | 45 | 1.0 (1.0–11.0) | 6 | 1.0 (1.0–15.0) |
Nausea | ||||||||
Mild | 8 | 1.8 (0.0–4.0) | 1 | 3.0 (3.0–3.0) | 8 | 2.5 (1.0–4.0) | 1 | 24.0 (24.0–24.0) |
Moderate | 3 | 0.0 (0.0–3.0) | 1 | 2.0 (2.0–2.0) | 3 | 2.0 (1.0–4.0) | 1 | 8.0 (8.0–8.0) |
Severe | 0 | - | 0 | - | 0 | - | 0 | - |
All | 11 | 1.6 (0.0–4.0) | 2 | 2.5 (2.0–3.0) | 11 | 2.0 (1.0–4.0) | 2 | 16.0 (8.0–24.0) |
Vomiting | ||||||||
Mild | 1 | 2.0 (2.0–2.0) | 0 | - | 1 | 1.0 (1.0–1.0) | 0 | - |
Moderate | 2 | 1.5 (0.0–3.0) | 0 | - | 2 | 2.0 (2.0–2.0) | 0 | - |
Severe | 0 | - | 0 | - | 0 | - | 0 | - |
All | 3 | 2.0 (0.0–3.0) | 0 | - | 3 | 2.0 (1.0–2.0) | 0 | - |
Fever | ||||||||
Mild | 14 | 1.2 (0.0–3.0) | 3 | 0.0 (0.0–1.4) | 14 | 2.0 (1.0–3.0) | 3 | 2.0 (1.0–5.0) |
Moderate | 1 | 3.0 (3.0–3.0) | 0 | - | 1 | 3.0 (3.0–3.0) | 0 | - |
Severe | 0 | - | 0 | - | 0 | - | 0 | - |
All | 15 | 1.3 (0.0–3.0) | 3 | 0.0 (0.0–1.4) | 15 | 2.0 (1.0–3.0) | 3 | 2.0 (1.0–5.0) |