Table 3.
Phase-I treatment-emergent adverse events in 19 patients with AD
| Adverse event by preferred term |
No. of subjects = 19 | |
|---|---|---|
| System organ class∗ | Preferred term | |
| Gastrointestinal disorders | Toothache | 1 (5.3%) |
| Vomiting | 1 (5.3%) | |
| General disorders and administration site conditions | Injection site hemorrhage | 1 (5.3%) |
| Injection site pain | 1 (5.3%) | |
| Injection site swelling | 4 (21.1%) | |
| Infections and infestations | Herpes zoster | 1 (5.3%) |
| Upper respiratory tract infection | 2 (10.5%) | |
| Injury, poisoning, and procedural complications | Burns first degree | 1 (5.3%) |
| Open wound | 1 (5.3%) | |
| Investigations† | Alanine aminotransferase increased | 3 (15.8%) |
| Aspartate aminotransferase increased | 2 (10.5%) | |
| Autoantibody positive | 2 (10.5%) | |
| Neutrophil count increased | 1 (5.3%) | |
| Neutrophil percentage increased | 1 (5.3%) | |
| Red blood cell sedimentation rate increased | 2 (10.5%) | |
| White blood cell count increased | 1 (5.3%) | |
| Metabolism and nutrition disorders | Decreased appetite | 1 (5.3%) |
| Hyperglycemia | 1 (5.3%) | |
| Nervous system disorders | Poor quality sleep | 1 (5.3%) |
| Dizziness | 1 (5.3%) | |
| Psychiatric disorders | Agitation | 4 (21.1%) |
| Obsessive-compulsive disorder | 1 (5.3%) | |
| Renal and urinary disorders | Genitourinary tract infection | 1 (5.3%) |
| Nephrolithiasis | 1 (5.3%) | |
| Reproductive system and breast disorders | Epididymitis | 1 (5.3%) |
| Respiratory, thoracic and mediastinal disorders | Cough | 2 (10.5%) |
| Skin and subcutaneous tissue disorders | Herpes zoster | 1 (5.3%) |
| Cellulitis | 1 (5.3%) | |
| Tinea cruris | 1 (5.3%) | |
Abbreviation: AD, Alzheimer's disease.
NOTE. Summary of treatment-emergent adverse events (AEs). The MedDRA system was used to code the AEs.
∗
The AEs were summarized descriptively by system organ class and preferred terms. AEs were classified into pretreatment and treatment-emergent AEs according to the time of occurrence. Treatment-emergent AEs, which were definitely, probably, or possibly related to the test drug, were regarded as treatment-related AEs. There were a total of 16 treatment-related AEs in 9 subjects (47.4%); the treatment-related AEs are indicated in bold type.
†
Laboratory evaluation.