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Table 5a Gastrointestinal adverse events reported in studies of arthritis patients (part 1)

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)
Gastrointestinal tolerability       
Celecoxib v placebo Any Placebo 19 9,919 5.3 4.6 1.0 (0.82–1.2)  
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 2.0 2.0 1.0 (0.43–2.4)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 5 2,671 3.2 4.4 0.72 (0.49–1.06)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 19 22,615 5.4 8.9 0.62 (0.56–0.68) 28 (24–36) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 19 23,743 5.5 8.9 0.61 (0.55–0.67) 29 (24–36) b
Celecoxib (any dose) v any active Any Any active comparator 25 27,334 5.2 8.0 0.63 (0.57–0.69) 35 (29–45) b
Nausea       
Celecoxib v placebo Any Placebo 17 9,510 2.7 3.4 0.76 (0.60–0.97) 155 (71–840) b
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 2.9 1.8 1.6 (0.73–3.7)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 4 1,579 1.8 2.8 0.62 (0.32–1.2)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 17 22,072 2.7 3.3 0.87 (0.74–1.02)  
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 18 31,168 3.8 5.6 0.80 (0.72–0.89) 56 (44–77) b
Celecoxib (any dose) v any active Any Any active comparator 23 33,667 3.7 5.3 0.81 (0.73–0.90) 63 (49–88) b
Vomiting       
Celecoxib v placebo Any Placebo 15 9,030 1.1 0.7 1.4 (0.86–2.4)  
Celecoxib v paracetamol Any Paracetamol 4,000 mg 2 1,056 0.7 1.0 0.73 (0.19–2.7)  
Celecoxib v rofecoxib Any Rofecoxib 25 mg 3 769 1.0 0.8 1.3 (0.29-5.7)  
Celecoxib (200/400) v NSAID 200–400 mg NSAID to maximum daily 16 21,825 0.8 1.4 0.64 (0.49–0.83) 173 (115–350) b
Celecoxib (any dose) v NSAID Any NSAID to maximum daily 17 30,921 1.2 1.9 0.75 (0.62–0.90) 144 (100–250) b
Celecoxib (any dose) v any active Any Any active comparator 21 32,610 1.2 1.9 0.76 (0.64–0.91) 156 (110–280) 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.