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Table 4 Overview of treatment-emergent adverse events

From: Diclofenac–hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial

  Hip Ankle Shoulder Elbow Total
DF-HA N = 46 Placebo N = 44 DF-HA N = 30 Placebo N = 30 DF-HA N = 45 Placebo N = 45 DF-HA N = 25 Placebo N = 25 DF-HA N = 146 Placebo N = 144
All events 24 (52.2) 15 (34.1) 15 (50.0) 10 (33.3) 23 (51.1) 18 (40.0) 10 (40.0) 9 (36.0) 72 (49.3) 52 (36.1)
Severity
 Mild 23 (50.0) 13 (29.5) 15 (50.0) 9 (30.0) 20 (44.4) 17 (37.8) 8 (32.0) 8 (32.0) 66 (45.2) 47 (32.6)
 Moderate 1 (2.2) 2 (4.5) 0 1 (3.3) 3 (6.7) 1 (2.2) 2 (8.0) 1 (4.0) 6 (4.1) 5 (3.5)
 Severe 0 0 0 0 0 0 0 0 0 0
Serious events 1 (2.2) 0 0 0 1 (2.2) 1 (2.2) 1 (4.0) 0 3 (2.1) 1 (0.7)
Events leading to study drug withdrawal 0 0 0 0 0 0 0 0 0 0
Common events (≥ 2%)a
 Nasopharyngitis 8 (17.4) 4 (9.1) 6 (20.0) 2 (6.7) 5 (11.1) 5 (11.1) 2 (8.0) 2 (8.0) 21 (14.4) 13 (9.0)
 Injection site joint pain 3 (6.5) 1 (2.3) 2 (6.7) 2 (6.7) 1 (2.2) 0 0 0 6 (4.1) 3 (2.1)
 Nausea 4 (8.7) 0 1 (3.3) 0 0 0 0 0 5 (3.4) 0
 Palpitations 2 (4.3) 0 0 0 1 (2.2) 0 0 0 3 (2.1) 0
 Arthralgia 0 0 1 (3.3) 2 (6.7) 0 2 (4.4) 0 0 1 (0.7) 4 (2.8)
Special-interest events
 Events at the injection siteb 3 (6.5) 2 (4.5) 4 (13.3) 3 (10.0) 3 (6.7) 0 0 2 (8.0) 10 (6.8) 7 (4.9)
 Gastrointestinal disordersc 0 0 0 0 1 (2.2) 0 0 0 1 (0.7) 0
 Cardiovascular disordersd 2 (4.3) 0 0 0 1 (2.2) 0 0 0 3 (2.1) 0
 Renal dysfunctione 0 0 0 0 1 (2.2) 0 0 0 1 (0.7) 0
 Hypersensitivityf 1 (2.2) 0 1 (3.3) 1 (3.3) 3 (6.7) 3 (6.7) 0 1 (4.0) 5 (3.4) 5 (3.5)
 Anaphylactic reactiong 3 (6.5) 0 1 (3.3) 0 1 (2.2) 2 (4.4) 0 2 (8.0) 5 (3.4) 4 (2.8)
  1. Data are presented as n (%)
  2. DF-HA diclofenac etalhyaluronate
  3. Classifications of adverse events are according to the Medical Dictionary for Regulatory Activities (MedDRA), version 22.0
  4. aTreatment-emergent adverse events (TEAEs) that occurred at a frequency of ≥2% in the DF-HA and/or placebo groups in total joints
  5. bInjection-site events included joint pain, bruising, eczema, hypoesthesia, injury, joint swelling, musculoskeletal pain, joint space narrowing, and cubital tunnel syndrome
  6. cStandardized MedDRA query (broad scope) term. TEAEs indicate gastrointestinal perforation, ulceration, hemorrhage, or obstruction
  7. dStandardized MedDRA query (broad scope) term. TEAEs indicate acute cardiac failure, ischemic heart disease, or cardiac arrhythmias
  8. eStandardized MedDRA query (broad scope) term. TEAEs indicate acute renal failure or chronic kidney disease
  9. fStandardized MedDRA query (broad scope) term. TEAEs indicate hypersensitivity
  10. gStandardized MedDRA query (broad scope) term. TEAEs indicate anaphylactic reaction