Table 2.
Treatment-related Treatment-Emergent Adverse Events in Part 2 Safety Population.
| System Organ Class Preferred Term | AXER-204 200 mg (N = 14) n (%) |
Placebo (N = 13) n (%) |
Total (N = 27) n (%) |
|---|---|---|---|
| Patients with any SAEs | 0 | 0 | 0 |
| Patients with any AEs | 10 (71%) | 9 (69%) | 19 (70%) |
| Nervous system disorders | 8 (57%) | 8 (62%) | 16 (59%) |
| Headache | 6 (43%) | 5 (39%) | 11 (41%) |
| Paresthesia | 2 (14%) | 4 (31%) | 6 (22%) |
| Muscle spasticity | 2 (14%) | 1 (8%) | 3 (11%) |
| Pleocytosis | 2 (14%) | 0 | 2 (7%) |
| Cerebrospinal fluid leakage | 0 | 1 (8 %) | 1 (4%) |
| Neuropathy peripheral | 1 (7%) | 0 | 1 (4%) |
| Musculoskeletal and connective tissue disorders | 3 (21%) | 2 (15%) | 5 (19%) |
| Back pain | 1 (7%) | 1 (8%) | 2 (7%) |
| Muscle tightness | 1 (7%) | 1 (8%) | 2 (7%) |
| Muscular weakness | 1 (7%) | 0 | 1 (4%) |
| Myalgia | 1 (7%) | 0 | 1 (4%) |
| Neck pain | 1 (7%) | 0 | 1 (4%) |
| Gastrointestinal disorders | 1 (7%) | 2 (15%) | 3 (11%) |
| Constipation | 0 | 1 (8%) | 1 (4%) |
| Nausea | 0 | 1 (8%) | 1 (4%) |
| Odynophagia | 1 (7%) | 0 | 1 (3.7%) |
| Investigations | 3 (21%) | 0 | 3 (11%) |
| Blood pressure increased | 1 (7%) | 0 | 1 (4%) |
| Body temperature decreased | 1 (7%) | 0 | 1 (4%) |
| CSF white blood cell count increased | 1 (7%) | 0 | 1 (4%) |
| General disorders and administration site conditions | 1 (7%) | 0 | 1 (4%) |
| Fatigue | 1 (7%) | 0 | 1 (4%) |
| Injury, poisoning and procedural complications | 0 | 1 (8%) | 1 (4%) |
| Autonomic dysreflexia | 0 | 1 (8%) | 1 (4%) |
| Skin and subcutaneous tissue disorders | 0 | 1 (8%) | 1 (4%) |
| Blister | 0 | 1 (8%) | 1 (4%) |
| Vascular disorders | 1 (7%) | 0 | 1 (4%) |
| Labile hypertension | 1 (7%) | 0 | 1 (4%) |
Abbreviations: SAE = serious adverse event; AE = adverse event; MedDRA = Medical Dictionary for Regulatory Activities; N = number of patients in Safety Population in each treatment group; n = number of patients with valid observations
Notes: Percentages were calculated based on N. All AEs included in the table are treatment-related treatment-emergent adverse events. Treatment-emergent AEs were events with a start date on or after the date of first dose of study treatment, or with a start date prior to the date of first dose of study treatment whose severity worsened on or after the date of first dose of study treatment. Treatment-emergent AEs were limited to those events that occurred within 28 days after the last visit. Treatment-related AEs included AEs considered by the investigator as definitely, probably, or possibly related to study treatment or with unknown/missing relationship to study treatment. Patients with more than 1 AE within a particular SOC were only counted once in that SOC. Patients with more than one AE within a particular PT were only counted once in that PT. The table is displayed in descending overall frequency by SOC and in descending overall frequency by PT within SOC, and then alphabetically. Adverse events were coded using the MedDRA Dictionary (Version 22.0).