TABLE 3.
TEAE | Total (n = 50) |
---|---|
Any TEAE | 50 (100) [509] |
Intensity of TEAEs | |
Mild | 47 (94.0) [297] |
Moderate | 39 (78.0) [171] |
Severe | 19 (38.0) [41] |
Causality of TEAEs | |
Related | 23 (46.0) [52] |
Not related | 50 (100) [456] |
Missing | 1 (2.0) [1] |
Intensity and causality of TEAEs | |
Mild and related | 20 (40.0) [33] |
Moderate and related | 8 (16.0) [14] |
Severe and related | 3 (6.0) [5] |
Missing and related | 0 |
TEAEs leading to treatment discontinuation | 5 (10.0) [8] |
TEAEs leading to study withdrawal | 4 (8.0) [4] |
TEAEs leading to death | 3 (6.0) a [3] |
Serious TEAEs | 12 (24.0) [34] |
Data are presented as number of patients (percentage of patient) [number of events]. Patients with several AEs of different intensities or causalities are counted once for each intensity/causality concerned.
LAN, lanreotide autogel; TEAE, treatment‐emergent adverse event.
None were related to treatment.