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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG in 1,650 patients in 9 placebo-controlled studies worldwide. The population was 19 to 97 years old, 68% were female, and 83% were Caucasian; 61% were undergoing bowel resection surgery. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Table 1 presents treatment-emergent adverse reactions reported in ≥ 3% patients treated with ENTEREG and for which the rate for ENTEREG was ≥ 1% than placebo. Treatment-emergent adverse reactions are those events occurring after the first dose of study medication treatment and within 7 days of the last dose of study medication or those events present at baseline that increased in severity after the start of study medication treatment.

Table 1. Treatment-Emergent Adverse Reactions That Were Reported in ≥ 3% of Either Bowel Resection Patients Treated With ENTEREG or All Surgical Patients Treated With ENTEREG and for Which the Rate for ENTEREG Was ≥ 1% Than Placebo

System Organ Class Bowel Resection Patients All Surgical Patients
Placebo
(n = 986)
%
ENTEREG
(n = 999)
%
Placebo
(n = 1,365)
%
ENTEREG
(n = 1,650)
%
Blood and lymphatic system disorders
  Anemia 4.2 5.2 5.4 5.4
Gastrointestinal disorders
  Constipation 3.9 4.0 7.6 9.7
  Dyspepsia 4.6 7.0 4.8 5.9
  Flatulence 4.5 3.1 7.7 8.7
Metabolism and nutrition disorders
  Hypokalemia 8.5 9.5 7.5 6.9
Musculoskeletal and connective tissue disorders
  Back pain 1.7 3.3 2.6 3.4
Renal and urinary disorders
  Urinary retention 2.1 3.2 2.3 3.5