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. Author manuscript; available in PMC: 2006 Feb 17.
Published in final edited form as: N Engl J Med. 2002 Feb 7;346(6):393–403. doi: 10.1056/NEJMoa012512

Table 3.

Adverse Events.

Event Placebo Metformin Lifestyle
Gastrointestinal symptoms (no. of events/100 person-yr)* 30.7 77.8 12.9
Musculoskeletal symptoms (no. of events/100 person-yr) 21.1 20.0 24.1
Hospitalization
 One or more admissions (% of participants) 16.1 15.9 15.6
 Rate (no. of admissions/100 person-yr) 7.9 8.4 8.0
 Median stay (days) 3 3 3
Deaths (no./100 person-yr) 0.16 0.20 0.10
*

Gastrointestinal symptoms included diarrhea, flatulence, nausea, and vomiting.

P<0.0167 for the comparison with placebo.

Most participants with musculoskeletal symptoms had myalgia, arthritis, or arthralgia.