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Table 4 Summary of adverse events

From: A multicenter randomized, double-blind, placebo-controlled pilot study to assess the efficacy and safety of riociguat in systemic sclerosis-associated digital ulcers

  Double-blind phase Open-label extension
PBO (n = 8) RIO (n = 9) PBO-RIO (n = 6) RIO-RIO (n = 6)
Treatment emergent AEs/SAEs 13 21 35 19
Treatment emergent AEs, n (%) 12 (92) 18 (86) 29 (83) 17 (90)
 Participants with AEs, n (%) 8 (100) 9 (100) 6 (100) 5 (83)
Treatment emergent SAEs, n (%) 1 (8) 4 (19) 6 (17) 2 (10)
 Participants with SAEs, n (%) 1 (13) 3 (33) 3 (50) 1 (17)
Participants with AEs leading to study drug discontinuation, n (%) 0 (0) 1 (11) 2 (33) 0 (0)
Participants with SAEs leading to study drug discontinuation, n (%) 0 (0) 0 (0) 1 (17) 0 (0)3
AEs according to system organ class, number of events (%)
 Blood and lymphatic system disorders 0 (0) 3 (14) 1 (3) 0 (0)
 Cardiac disorders 1 (8) 2 (10) 3 (9) 2 (11)
 Gastrointestinal disorders 1 (8) 2 (10) 9 (26) 4 (21)
 General disorders 1 (8) 0 (0) 3 (9) 2 (11)
 Hepatobiliary disorders 0 (0) 1 (5) 0 (0) 0 (0)
 Infections and infestations 1 (8) 2 (10) 6 (17) 2 (11)
 Injury, poisoning, and procedural complications 1 (8) 0 (0) 0 (0) 0 (0)
 Metabolism and nutrition disorders 0 (0) 0 (0) 0 (0) 1 (5)
 Musculoskeletal and connective tissue disorders 1 (8) 3 (14) 1 (3) 4 (21)
 Nervous system disorders 4 (31) 5 (24) 3 (9) 0 (0)
 Renal and urinary disorders 0 (0) 0 (0) 6 (17) 0 (0)
 Respiratory, thoracic and mediastinal disorders 0 (0) 0 (0) 1 (3) 3 (16)
 Surgical and medical procedures 1 (8) 0 (0) 0 (0) 0 (0)
 Vascular disorders 2 (15) 3 (14) 1 (3) 1 (5)
SAEs according to system organ class, number of events (%)
 Blood and lymphatic system disorders
  Lymphoma 0 (0) 1 (33) 0 (0) 0 (0)
 Cardiac disorders
  NSTEMI 0 (0) 1 (33) 0 (0) 0 (0)
 Gastrointestinal disorders
  Acute ileus 0 (0) 0 (0) 1 (17) 0 (0)
  Omental adhesions of lower abdomen 0 (0) 0 (0) 1 (17) 0 (0)
 Infections and infestations
  Aspiration pneumonia 0 (0) 0 (0) 1 (17) 0 (0)
 Musculoskeletal and connective tissue disorders
  Acute right rib fractures with hemopneumothorax 0 (0) 0 (0) 0 (0) 1 (17)
 Nervous system disorders
  Possible transient ischemic attack 0 (0) 0 (0) 1 (17) 0 (0)
 Respiratory, thoracic, and mediastinal disorders
  Acute respiratory failure secondary to pneumonia 0 (0) 0 (0) 1 (17) 0 (0)
 Vascular disorders
  Digital ischemia 1 (100) 1 (33) 0 (0) 0 (0)
  DU 0 (0) 1 (33) 0 (0) 0 (0)
  Deep vein thrombosis 0 (0) 0 (0) 1 (17) 0 (0)
  Pulmonary embolism 0 (0) 0 (0) 0 (0) 1 (17)
  1. Safety analysis set for the double-blind treatment period. Values are the number (%)
  2. AEs adverse events, SAEs serious adverse events, NSTEMI non-ST elevation myocardial infarction, DU digital ulcer
  3. According to the Medical Dictionary for Regulatory Activities, version 18.0