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Table 4 Analysis of arthritis patients according to gastrointestinal adverse events

From: Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial reports

    Number of Incidence of events (%)   
Outcome and comparisons Celecoxib daily dose Comparator and daily dose Trials Patients Celecoxib Comparator Relative riska (95% CI) NNTpb or NNHc (95% CI)
Patient with any adverse event       
Celecoxib v placebo Any Placebo 19 9,919 55 48 1.08 (1.04–1.13) a 15 (11–21)c
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 32 32 1.0 (0.84–1.2)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 3 769 48 49 0.97 (0.84–1.1)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 19 22,615 45 50 0.92 (0.89–0.95) a 18 (14–23) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 20 31,711 53 60 0.96 (0.94–0.98) a 15 (13–18) b
Celecoxib (any dose) v any active Any Any active comparator 24 33,400 53 59 0.96 (0.94–0.98) a 17 (14–21) b
Patient with any treatment-related adverse event       
Celecoxib v placebo Any Placebo 19 9,919 9.5 8.1 1.22 (1.06–1.40) a 71 (39–450)c
Celecoxib v paracetamol Any Paracetamol 4,000 mg 3 1,056 9.0 8.8 1.04 (0.71–1.5)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 4 1,579 6.6 9.0 0.74 (0.53–1.04)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 19 22,615 13.0 17.3 0.77 (0.72–0.82) a 24 (19–31) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 19 23,743 12.7 17.3 0.77 (0.72–0.82) a 22 (18–27) b
Celecoxib (any dose) v any active Any Any active comparator 24 26,242 12.3 16.2 0.78 (0.73–0.83) a 26 (21–33) b
Patient with any serious adverse event       
Celecoxib v placebo Any Placebo 19 9,919 1.0 1.4 0.67 (0.46–0.98) a 280 (120–790) b
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 0.5 0.6 0.76 (0.14–4.1)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 5 2,671 2.3 2.1 1.1 (0.68–1.9)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 19 22,612 2.5 2.6 0.91 (0.77–1.08)  
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 20 31,708 3.3 3.6 1.02 (0.91–1.15)  
Celecoxib (any dose) v any active Any Any active comparator 26 35,299 3.2 3.4 1.02 (0.91–1.15)  
Patient with any gastrointestinal adverse event       
Celecoxib v placebo Any Placebo 17 9,512 26.0 19.0 1.2 (1.1–1.4) a 14 (12–19)c
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 12.0 11.0 1.1 (0.8–1.6)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 5 2,671 16.0 18.0 0.87 (0.74–1.03)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 18 30,043 26.0 34.0 0.84 (0.81–0.87) a 12 (10–13) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 18 31,171 26.0 34.0 0.84 (0.81–0.87) a 12 (10–13) b
Celecoxib (any dose) v any active Any Any active comparator 24 34,762 26.0 32.0 0.85 (0.82–0.88) a 14 (12–16) b
  1. aRelative risk: bold indicates statistically significant difference. bNNTp (number-needed-to-treat to prevent one event) is indicated by bold. cNNH (number-needed-to-treat to harm one patient). CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug.