Table 3.

Adverse events on therapy plus 1 d (N = 302)

Adverse eventsPatients, n (%)
Any AE 277 (92) 
 AEs occurring in 10% or more patients  
  Headache 86 (28) 
  Nasopharyngitis 74 (25) 
  Upper respiratory tract infection 69 (23) 
  Fatigue 50 (17) 
  Diarrhea 47 (16) 
  Arthralgia 45 (15) 
  Back pain 40 (13) 
  Urinary tract infection 34 (11) 
  Nausea 34 (11) 
  Cough 32 (11) 
  Influenza 30 (10) 
  Anemia 29 (10) 
Any SAE 96 (32) 
 SAEs occurring in 4 (≥1%) or more patients  
  Cataracts* 16 (5) 
  Pneumonia 8 (3) 
  Anemia 5 (2) 
  ALT increase 5 (2) 
  Epistaxis 4 (1) 
  AST increase 4 (1) 
  Bilirubin increase 4 (1) 
  Deep vein thrombosis 4 (1) 
Adverse eventsPatients, n (%)
Any AE 277 (92) 
 AEs occurring in 10% or more patients  
  Headache 86 (28) 
  Nasopharyngitis 74 (25) 
  Upper respiratory tract infection 69 (23) 
  Fatigue 50 (17) 
  Diarrhea 47 (16) 
  Arthralgia 45 (15) 
  Back pain 40 (13) 
  Urinary tract infection 34 (11) 
  Nausea 34 (11) 
  Cough 32 (11) 
  Influenza 30 (10) 
  Anemia 29 (10) 
Any SAE 96 (32) 
 SAEs occurring in 4 (≥1%) or more patients  
  Cataracts* 16 (5) 
  Pneumonia 8 (3) 
  Anemia 5 (2) 
  ALT increase 5 (2) 
  Epistaxis 4 (1) 
  AST increase 4 (1) 
  Bilirubin increase 4 (1) 
  Deep vein thrombosis 4 (1) 
*

The study protocol required that cataracts be reported as SAEs.

DVTs listed here were categorized by the preferred term. One patient had 2 DVTs. Another patient was classified as having thrombosis and then later considered to have had a DVT.

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