Randomized Clinical Trial
Copyright ©The Author(s) 2016.
World J Gastrointest Pharmacol Ther. May 6, 2016; 7(2): 274-282
Published online May 6, 2016. doi: 10.4292/wjgpt.v7.i2.274
Table 4 Summary of treatment-emergent adverse events, safety population n (%)
SummaryTreatment group
PEG 3350Placebo
Total subjects102101
Total subjects with an adverse event14 (13.7)17 (16.8)
Nervous system disorders11 (10.8)11 (10.9)
Headache11 (10.8)11 (10.9)
Migraine1 (< 1.0)0
Musculoskeletal and connective tissue disorders3 (2.9)2 (2.0)
Back pain02 (2.0)
Neck pain2 (2.0)0
Arthralgia1 (< 1.0)0
Gastrointestinal disorders04 (4.0)
Nausea02 (2.0)
Abdominal distension01 (< 1.0)
Dyspepsia01 (< 1.0)
Infections and infestations1 (< 1.0)1 (< 1.0)
Nasopharyngitis1 (< 1.0)0
Sinusitis01 (< 1.0)
Psychiatric disorders1 (< 1.0)1 (< 1.0)
Insomnia1 (< 1.0)1 (< 1.0)
Respiratory, thoracic, and mediastinal disorders2 (2.0)0
Nasal congestion1 (< 1.0)0
Pharyngolaryngeal pain1 (< 1.0)0