Table 2.
TRAEs occurring at any grade in ≥ 5% of patients or of grade 3/4 severity, and any AEs of special interest
| Preferred term, n (%) | N = 30 | |
|---|---|---|
| Any grade | Grade 3/4 | |
| TRAEs | ||
| TRAE | 19 (63.3) | 7 (23.3) |
| Maculopapular rash | 6 (20.0) | 1 (3.3) |
| Rash | 5 (16.7) | 1 (3.3) |
| Hypothyroidism | 5 (16.7) | 0 |
| Interstitial lung disease | 3 (10.0) | 1 (3.3)a |
| KA | 3 (10.0) | 0 |
| Pruritus | 3 (10.0) | 0 |
| Blood creatinine increased | 2 (6.7) | 0 |
| Eczema | 2 (6.7) | 1 (3.3) |
| Hyperthyroidism | 2 (6.7) | 0 |
| Retinal hemorrhage | 2 (6.7) | 0 |
| Amylase increased | 1 (3.3) | 1 (3.3) |
| Blood creatine phosphokinase increased | 1 (3.3) | 1 (3.3)b |
| Lichenoid keratosis | 1 (3.3) | 1 (3.3) |
| Lip SCC | 1 (3.3) | 1 (3.3) |
| Any AE of special interest | ||
| Skin lesionsc | 4 (13.3) | 1 (3.3) |
| Any irAE | 12 (40.0)d | 4 (13.3) |
| Immune-related rash | 10 (33.3) | 2 (6.7) |
| Immune-related thyroid disorders | 3 (10.0) | 0 |
| Immune-related interstitial lung disease | 2 (6.7) | 1 (3.3)a |
| Other irAEs | 1 (3.3) | 1 (3.3) |
AE adverse event, irAE immune-related adverse event, KA keratoacanthoma, NCI-CTCAE v4.03 National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, SCC squamous cell carcinoma, TRAE treatment-related adverse event
aGrade 4; was later re-evaluated by the investigator as grade 3 pneumonia
bGrade 4
cIncludes actinic keratosis, basal cell carcinoma, Bowen’s disease, hyperkeratosis, KA, lip SCC, and SCC of skin NCI-CTCAE v4.03 preferred terms
dSeven patients experienced multiple different irAEs