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.