Table 3.

AEs and serious AEs for GC and TAC therapy

AEsGC Group (128 Reports, 49 Patients), n=56TAC Group (81 Reports, 43 Patients), n=63
Infection
 Urinary tract infection34
 Female genital tract infection11
 Upper respiratory infection1312
 Lower respiratory tract infection2 (1 SAE)2
 Abdominal cavity infection1 (1 SAE)
Gastrointestinal symptoms89
Hepatotoxicity13 (1 SAE)10 (1 SAE)
AKI4 (1 SAE)3 (1 SAE)
New-onset hypertension104
Metabolic disorder
 New–onset glucose intolerance64
 New–onset diabetes mellitus3 (2 SAE)
 New-onset hyperuricemia611
 Other31
Osteoporosis51
Electrolyte disorder32
Arrhythmia11
Menstrual disorders4
Psychiatry/neurology4 (1 SAE)3
Cushing syndrome20
Symptoms of skin, muscle, and joint
 Cramps31
 Arthralgia22
 Hypertrichosis1
 Cutaneous ulcer1
 Erythra42
 Alopecia13
 Purple stripes5
 Acne6
  • SAE, serious adverse event.