Table 3.
Comparing IRAE rates between Ab + and Ab −, NAb + and NAb −: negative binomial regression model.
| Model | Independent variable | Estimated IRAE rate | RR | 95% CI | P-value |
|---|---|---|---|---|---|
| Ab ± | |||||
| 1 | IgG antibody status | 2.873 | 0.731, 11.296 | 0.1309 | |
| Ab + | 0.0121 | ||||
| Ab − | 0.0042 | ||||
| 2 | IgG antibody status | 2.082 | 0.563, 7.706 | 0.2718 | |
| Ab + | 0.0055 | ||||
| Ab − | 0.0026 | ||||
| Age at study entry | 6.79 | 0.766, 60.225 | 0.0854 | ||
| < 12 Years | 0.0099 | ||||
| ≥ 12 Years | 0.0015 | ||||
| NAb ± | |||||
| 1 | IgG antibody status | 2.976 | 0.788, 11.239 | 0.1078 | |
| NAb + | 0.0148 | ||||
| NAb − | 0.0050 | ||||
| 2 | IgG antibody status | 2.264 | 0.661, 7.755 | 0.1934 | |
| NAb + | 0.0066 | ||||
| NAb − | 0.0029 | ||||
| Age at study entry | 6.848 | 0.782, 59.932 | 0.0822 | ||
| < 12 Years | 0.0114 | ||||
| ≥ 12 Years | 0.0017 | ||||
The IRAE average weekly rates, RR with 95% CI and P-value are based on the negative binomial model. The dependent variable is the count of the number of IRAEs, and the offset variable is the natural log of the time in weeks from first study infusion to last on-study assessment (Week 109 or early termination).
Ab +, antibody positive; Ab −, antibody negative; IRAE, infusion-related adverse event; NAb +, neutralizing antibody positive, NAb −, neutralizing antibody negative; RR, relative risk.