Skip to main content

Table 1 (abstract O2). Overview of the CAN safety data of the RELIANCE study across all study indications (N=168 patients)

From: Proceedings of the 27th European Paediatric Rheumatology Congress (PReS 2021)

Type of event

Number of events

IR‡

AE total

489

173.33

AE non-serious

436

154.33

AE, non-serious, not related

221

78.34

AE, ARI

13

4.61

AE, non-serious adverse drug reaction

215

76.21

SAE, total

53

18.79

SAE, not related

32

11.34

SADR#, total

21

7.44

  1. #Alport's syndrome, appendicitis, blister, cardiovascular disorder, chest pain, circulatory collapse, erythema, febrile convulsion, glomerulonephritis, Hemophilus test positive, pneumonia, premature delivery, skin discoloration, tonsillitis bacterial, tonsillitis streptococcal (each n=1 event, IR 0.4‡), tonsillectomy (2 events, IR 0.7‡), pyrexia (3 events, IR 1.1‡), not yet coded (hospital admission due to exsiccosis upon gastroenteritis, 1 event, IR 0.4‡)
  2. ‡IR, incidence rate per 100 patient years; AE, adverse event; SAE, severe adverse event, SADR, severe adverse drug reaction