Table 2

Adverse events

Arm 3Arm 4
Grade 1Grade 2Grade 3Grade 4Grade 1Grade 2Grade 3Grade 4
Endocrine
 Adrenal insufficiency1
 Hyperthyroidism/decreased TSH23132
 Hypothyroidism/increased TSH54
Gastrointestinal
 Abdominal pain11
 Colitis12
 Diarrhea1132
 Nausea131
 Vomiting21
General
 Chills35
 Fatigue33101
 Injection site reaction55
Laboratory investigations
 Increased AST11
 Increased amylase11
Metabolism and nutrition
 Hyperglycemia11
Musculoskeletal and connective tissue
 Arthralgias/arthritis13
 Back pain11
 Bone pain111
 Muscle weakness11
 Myalgia22
Nervous system
 Dizziness211
 Headache22
Respiratory, thoracic
 Hypoxia1
Skin and subcutaneous
 Pruritus111
 Rash maculopapular1121
  • 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.