Table 4:
Concordance of reporting thresholds between AEs any grade and grade≥3 (n=141*)
| Number of patients with AE |
Same threshold AE any grade and grade ≥3 (N=100) |
Discordant thresholds between AE any grade and grade ≥3 (N=41)** |
|
|---|---|---|---|
| Any grade | Grade ≥3 | ||
| 1-2 patients | 39 (39%) | 5 (12%)† | 32 (78%) |
| 5-10% incidence | 44 (44%) | 19 (46%) | 9 (21%) |
| 15-20% incidence | 15 (15%) | 14 (34%) | - |
| >=25% incidence | 2 (2%) | 3 (7%) | - |
| Total | 100 | 41 | 41 |
141/209 (67%) displayed reporting thresholds for both AEs of any grade and grade ≥3. 68 trials did not disclose the threshold used for reporting either or both AEs of any grade and grade ≥3.
41 studies had different thresholds for AEs of any grade versus grade≥3 which are represented in both columns.
These 5 studies used a threshold of 2 patients to report AEs of any grade and 1 patient to report AEs grade ≥3