Summary of treatment emergent adverse events occurring in at least two participants by treatment group – safety population
| Category | Number of participants: n (%) | |
| GAI (N=154) | GEK (N=157) | |
| Any treatment emergent adverse events | 71 (46.1) | 52 (33.1) |
| Preferred term: | ||
| Diarrhea | 2 (1.3) | 1 (0.6) |
| Nausea | 46 (29.9) | 36 (22.9) |
| Vomiting | 25 (16.2) | 15 (9.6) |
| Injection site pain | 2 (1.3) | 1 (0.6) |
| Upper respiratory tract infection | 2 (1.3) | 0 |
| Dizziness* | 2 (1.3) | 1 (0.6) |
| Headache | 8 (5.2) | 6 (3.8) |
Results presented have been pooled from both XSGP-301 and XSGP-303 and are presented by treatment.
Only preferred terms that resulted in two or more participants experiencing the event within the same treatment are included in this table.
Adverse events were coded using Medical Coding Dictionary for Regulatory Activities (MedDRA), V.20.0.
*Dizziness is coded under the system organ class ‘nervous system disorders’.
GAI, glucagon autoinjector; GEK, glucagon emergency kit.