Table 2.
Treatment-emergent skin reactions leading to dose modification or withdrawal in EV-301.
| Preferred term | EV-301 N = 296, n (%) |
|---|---|
| Skin reactions leading to dose reduction | |
| Any skin reaction | 24 (8) |
| Any severe cutaneous adverse reactiona | 5 (2) |
| Rash maculopapular | 13 (4) |
| Rash erythematous | 1 (<1) |
| Rash vesicular | 1 (<1) |
| Drug eruptiona | 4 (1) |
| Rash | 3 (1) |
| Stomatitisa | 1 (<1) |
| Eczema | 1 (<1) |
| Erythema | 1 (<1) |
| Perivascular dermatitis | 1 (<1) |
| Skin reactions leading to dose interruption | |
| Any skin reaction | 33 (11) |
| Any severe cutaneous adverse reactiona | 14 (5) |
| Rash maculopapular | 13 (4) |
| Rash | 10 (3) |
| Rash erythematous | 1 (<1) |
| Drug eruptiona | 7 (2) |
| Dermatitis bullousa | 3 (1) |
| Dermatitis acneiform | 2 (1) |
| Blistera | 1 (<1) |
| Conjunctivitisa | 1 (<1) |
| Fixed eruptiona | 1 (<1) |
| Skin exfoliationa | 1 (<1) |
| Stomatitisa | 1 (<1) |
| Skin reactions leading to treatment withdrawal | |
| Any skin reaction | 12 (4) |
| Any severe cutaneous adverse reactiona | 6 (2) |
| Rash maculopapular | 4 (1) |
| Drug eruptiona | 2 (1) |
| Dermatitis bullousa | 2 (1) |
| Rash | 1 (<1) |
| Rash erythematous | 1 (<1) |
| Conjunctivitisa | 1 (<1) |
| Toxic skin eruptiona | 1 (<1) |
a
Severe cutaneous adverse reactions were reported as a composite term of dermatologic and non-dermatologic events for based on standardized Medical Dictionary for Regulatory Activities v23.0 query.
Data on file.