Table 7 Adverse events: treatment emergent signs and symptoms (TESS) - those not seen at baseline. Number observed and rate with patient identification
Group | Number of patients | Number of AE/group, | Patient’s treatment code | Adverse events |
|---|---|---|---|---|
Placebo | 68 | 5.9% | 10 | Meteorism, gastro-esophageal reflux |
86 | Weight gain after 28 days of treatment | |||
171 | Stomach pain, dyspepsia, gastroesophageal reflux disease. | |||
202 | Relapsing rash and itching at lower extremities which improved after medication withdrawal | |||
Curamed | 66 | 10.6% | 2 | Nausea for 2–3 days |
3 | Meteorism, gastro-esophageal reflux, stomach pain | |||
34 | Swelling of ankle joints | |||
105 | Stomach pain, dyspepsia, gastroesophageal reflux for 5–6 days | |||
154 | Bitter taste in mouth for a week | |||
185 | Nausea, vomiting, | |||
186 | Nausea for 2–3 days | |||
Curamin | 67 | 3.0% | 175 | Nausea, vomiting |
181 | Nausea, heart beating |