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. 2015 Mar 17;80(3):436–445. doi: 10.1111/bcp.12633

Table 2.

Time course of adverse events (AEs) utilizing multiple increasing doses of custirsen (group B only)

Day 2 Day 4 Day 6 Day 8
n (%) 320 mg(n =12) 480 mg(n =12) 640 mg(n =11) 640 mg(n =11)
Subjects with at least one AE* 5 (42) 6 (50) 4 (36) 11 (100)
Constitutional AEs
  Myalgia 4 (33) 4 (33) 0 0
  Chills 2 (17) 2 (17) 0 0
  Fatigue 1 (8) 0 0 0
  Pyrexia 1 (8) 2 (17) 0 0
  Dizziness 1 (8) 0 0 0
  Headache 1 (8) 3 (25) 1 (9) 0
  Flushing 0 1 (8) 0 0
Other AEs
  Activated partial thromboplastin time prolonged 0 0 0 11 (100)
  Alanine aminotransferase increased 0 0 3 (27) 0
  Aspartate aminotransferase increased 0 0 1 (9) 0
  Gamma glutamyl transferase increased 0 0 1 (9) 0
  Muscle spasms 0 1 (8) 0 0
  Eye pain 0 1 (8) 0 0
  Blurred vision 1 (8) 0 0 0
*

Events with onset on or after first dose of study drug (on-study events). All events listed according to MedDRA Version 15.0 preferred term.