Table 2.
Adverse events
| Arm 3 | Arm 4 | |||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Endocrine | ||||||||
| Adrenal insufficiency | 1 | |||||||
| Hyperthyroidism/decreased TSH | 2 | 3 | 1 | 3 | 2 | |||
| Hypothyroidism/increased TSH | 5 | 4 | ||||||
| Gastrointestinal | ||||||||
| Abdominal pain | 1 | 1 | ||||||
| Colitis | 1 | 2 | ||||||
| Diarrhea | 1 | 1 | 3 | 2 | ||||
| Nausea | 1 | 3 | 1 | |||||
| Vomiting | 2 | 1 | ||||||
| General | ||||||||
| Chills | 3 | 5 | ||||||
| Fatigue | 3 | 3 | 10 | 1 | ||||
| Injection site reaction | 5 | 5 | ||||||
| Laboratory investigations | ||||||||
| Increased AST | 1 | 1 | ||||||
| Increased amylase | 1 | 1 | ||||||
| Metabolism and nutrition | ||||||||
| Hyperglycemia | 1 | 1 | ||||||
| Musculoskeletal and connective tissue | ||||||||
| Arthralgias/arthritis | 1 | 3 | ||||||
| Back pain | 1 | 1 | ||||||
| Bone pain | 1 | 1 | 1 | |||||
| Muscle weakness | 1 | 1 | ||||||
| Myalgia | 2 | 2 | ||||||
| Nervous system | ||||||||
| Dizziness | 2 | 1 | 1 | |||||
| Headache | 2 | 2 | ||||||
| Respiratory, thoracic | ||||||||
| Hypoxia | 1 | |||||||
| Skin and subcutaneous | ||||||||
| Pruritus | 1 | 1 | 1 | |||||
| Rash maculopapular | 1 | 1 | 2 | 1 | ||||
All adverse events with a frequency >5%, and any adverse events with grade >grade 2, that were believed to be at least possibly related to treatment are shown for patients treated in arms 3 and 4. The numbers represent the number of patients experiencing a particular event at any point during the treatment period, with the highest grade reported for any single individual.
TSH, thyroid-stimulating hormone.