Table 10 Summary of analysis of adverse events in all subjects
Study group | |||
|---|---|---|---|
Placebo (n = 58) | GC (n = 65) | UCII (n = 63) | |
Severity | |||
Mild | 7 | 21 | 5 |
Moderate | 2 | 7 | 3 |
Severe | 0 | 0 | 0 |
Relationship to Test Article | |||
Not related | 8 | 14 | 8 |
Possible | 1 | 13 | 0 |
Definite | 0 | 1 | 0 |
Body System and AEs | |||
Gastrointestinal | |||
Acidity | 2 | 3 | 2 |
Acute peptic disorder | 1 | 0 | 1 |
Diarrhea | 1 | 1 | 0 |
Epigastric burning | 0 | 1 | 0 |
Febrile Enteritis | 0 | 1 | 0 |
Heart burn | 0 | 1 | 0 |
Vomiting | 0 | 1 | 0 |
Nausea | 0 | 1 | 0 |
Pain | |||
Arthralgia | 0 | 1 | 0 |
Body pain | 0 | 1 | 0 |
Low back pain | 1 | 1 | 0 |
Neck Pain | 0 | 1 | 1 |
Headache | 2 | 4 | 0 |
Myalgia | 0 | 1 | 0 |
Dermatology | |||
Itching | 0 | 2 | 0 |
Xerotic skin | 0 | 0 | 1 |
Pulmonary/Upper Respiratory | |||
Lower respiratory tract infection | 0 | 0 | 2 |
Upper respiratory tract infection | 0 | 1 | 0 |
Cough | 0 | 2 | 0 |
Genitourinary | |||
Burning micturition | 1 | 0 | 0 |
Burning sensation | 0 | 0 | 1 |
Cardiovascular | |||
Palpitation | 0 | 2 | 0 |
Constitutional Symptoms | |||
Fever | 1 | 2 | 0 |
Insomnia | 0 | 1 | 0 |
Total Number of Adverse Events Experienced During Study | 9 | 28 | 8 |
Total Number of Subjects Experiencing Adverse Events: n (%) | 7/58 (12 %) | 20/65 (31 %) | 8/63 (13 %) |