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Table 5b Gastrointestinal adverse events reported in studies of arthritis patients (part 2)

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/ comparisons Celecoxib daily dose Comparator and daily dose Trials Patients Celecoxib Comparator Relative riska (95% CI) NNTpb or NNHc (95% CI)
Abdominal pain       
Celecoxib v placebo Any Placebo 19 9,919 3.6 2.9 1.2 (0.92–1.5)  
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 0.9 2.0 0.45 (0.15–1.3)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 5 2,671 2.7 4.2 0.64 (0.42–0.97) a 67 (35–920) b
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 19 22,615 5.3 7.8 0.75 (0.68–0.83) a 41 (32–57) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 20 31,711 6.6 10.0 0.76 (0.70–0.82) a 29 (25–36) b
Celecoxib (any dose) v any active Any Any active comparator 26 35,302 6.2 9.2 0.75 (0.70–0.81) a 33 (28–41) b
Dyspepsia       
Celecoxib v placebo Any Placebo 19 9,919 6.9 4.8 1.30 (1.08–1.6) a 46 (32–84)c
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 2.9 2.2 1.34 (0.63–2.9)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 5 2,671 4.4 4.9 0.89 (0.63–1.3)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 19 22,615 5.7 7.3 0.79 (0.71–0.88) a 61 (43–100) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 20 31,711 8.1 10.7 0.84 (0.78–0.90) a 39 (31–52) b
Celecoxib (any dose) v any active Any Any active comparator 26 35,302 7.8 9.9 0.85 (0.79–0.91) a 48 (37–68) b
Diarrhoea       
Celecoxib v placebo Any Placebo 17 9,510 5.1 3.5 1.45 (1.16–1.82) a 53 (37–97)c
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 2.2 4.6 0.48 (0.24–0.95) a 41 (22–450) b
Celecoxib v rofecoxib Any Rofecoxib 25 mg 5 2,671 4.1 4.4 0.93 (0.65–1.3)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 17 22,071 4.3 4.9 0.96 (0.85–1.1)  
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 18 31,167 5.8 6.9 0.96 (0.88–1.1)  
Celecoxib (any dose) v any active Any Any active comparator 24 34,758 5.6 6.6 0.95 (0.87–1.03)  
Clinical ulcers and bleeds       
Celecoxib v placebo Any Placebo 16 9,321 0.03 0.05   3 events
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 0.0 0.0   0 events
Celecoxib v rofecoxib Any Rofecoxib 25 mg 3 897 0.3 0.0   1 event
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 17 22,075 0.2 0.6 0.35 (0.22–0.56) a 250 (170–450) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 18 31,171 0.4 0.9 0.61 (0.46–0.81) a 200 (140–320) b
Celecoxib (any dose) v any active Any Any active comparator 22 32,508 0.4 0.8 0.61 (0.46–0.81) a 210 (150–350) 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.