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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
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Arthritis Research & Therapy

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