Table 2.
Adverse Events by Treatment Group
| Treatment Group
|
|||||
|---|---|---|---|---|---|
| 3 g | 6 g | 10 g | All ManNAc | Placebo | |
|
| |||||
| Number of Subjects | 4 | 6 | 6 | 16 | 6 |
|
| |||||
| Adverse Events by SOC | |||||
| Nervous system disorders | 3 (75.0%) | 1 (16.7%) | 3 (50.0%) | 7 (43.8%) | 2 (33.3%) |
| Headache* | 3 (75.0%) | 1 (16.7%) | 2 (33.3%) | 6 (37.5%) | 2 (33.3%) |
| Dizziness* | 1 (25.0%) | 0 | 1 (16.7%) | 2 (12.5%) | 0 |
| Blood and lymphatic system disorders | 1 (25.0%) | 1 (16.7%) | 2 (33.3%) | 4 (25.0%) | 1 (16.7%) |
| Anemia | 1 (25.0%) | 1 (16.7%) | 1 (16.7%) | 3 (18.8%) | 1 (16.7%) |
| Hypocalcemia | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| General disorders | 2 (50.0%) | 0 | 1 (16.7%) | 3 (18.8%) | 2 (33.3%) |
| Fatigue | 2 (50.0%) | 0 | 0 | 2 (12.5%) | 2 (33.3%) |
| Pain left shoulder | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Musculoskeletal and connective tissue disorders | 0 | 1 (16.7%) | 2 (33.3%) | 3 (18.8%) | 1 (16.7%) |
| Increased CPK | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 1 (16.7%) |
| Back Pain | 0 | 1 (16.7%) | 0 | 1 (6.3%) | 0 |
| Increased LDH | 0 | 0 | 0 | 0 | 1 (16.7%) |
| Hip pain | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Gastrointestinal disorders | 0 | 0 | 3 (50.0%) | 3 (18.8%) | 0 |
| Diarrhea* | 0 | 0 | 3 (50.0%) | 3 (18.8%) | 0 |
| Nausea* | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Hepatobiliary disorders | 0 | 0 | 2 (33.3%) | 2 (12.5%) | 1 (16.7%) |
| Increased AST* | 0 | 0 | 2 (33.3%) | 2 (12.5%) | 1 (16.7%) |
| Increased ALT* | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 1 (16.7%) |
| Increased GGT* | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Immune system disorders | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 2 (33.3%) |
| Allergic Rhinitis | 0 | 0 | 0 | 0 | 1 (16.7%) |
| Increased ESR | 0 | 0 | 0 | 0 | 1 (16.7%) |
| Increased eosinophils | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Infections and infestations | 0 | 0 | 2 (33.3%) | 2 (12.5%) | 0 |
| Bacterial pharyngitis | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Upper Respiratory Infection | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Skin and subcutaneous tissue disorders | 0 | 0 | 2 (33.3%) | 2 (12.5%) | 0 |
| Palmar rash and tenderness bilaterally | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Rash | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Injury, poisoning and procedural complications | 0 | 0 | 0 | 0 | 1 (16.7%) |
| Injection site reaction | 0 | 0 | 0 | 0 | 1 (16.7%) |
| Metabolism and nutrition disorders | 0 | 1 (16.7%) | 0 | 1 (6.3%) | 0 |
| Hyperglycemia* | 0 | 1 (16.7%) | 0 | 1 (6.3%) | 0 |
| Vascular disorders | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
| Hypotension | 0 | 0 | 1 (16.7%) | 1 (6.3%) | 0 |
Abbreviations: SOC: System Organ Class
Note: Events are sorted in decreasing frequency by percent of overall subjects with the event by SOC and verbatim terms within SOC.
*
Denotes AEs identified to be possibly or probably related to study drug administration. Other AEs were considered to be unlikely or not related.