Clinical Study
The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain
Table 3
Cumulative summary of treatment emergent adverse events over time.
| | Week 2 (100 mg 5-ALA-SFC) () | Week 4 (150 mg 5-ALA-SFC) () | Week 6 (200 mg 5-ALA-SFC) () | Week 12 (200 mg 5-ALA-SFC) () | Week 12 (Placebo) () |
| Subjects reporting at least one event | 6 (17.1%) | 14 (40.0%) | 15 (42.9%) | 16 (45.7%) | 5 (27.8%) |
| Abdominal distension | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Abdominal pain upper | 1 (2.9%) | 2 (5.7%) | 2 (5.7%) | 2 (5.7%) | 0 | Alopecia | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Blood glucose increased | 0 | 0 | 1 (2.9%) | 1 (2.9%) | 0 | Constipation | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Cough | 1 (2.9%) | 2 (5.7%) | 2 (5.7%) | 2 (5.7%) | 0 | Decreased appetite | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Diarrhea | 2 (5.7%) | 2 (5.7%) | 2 (5.7%) | 2 (5.7%) | 2 (11.1%) | Dyspepsia | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 1 (5.6%) | Erectile dysfunction | 0 | 0 | 1 (2.9%) | 1 (2.9%) | 0 | Fatigue | 0 | 1 (2.9%) | 2 (5.7%) | 2 (5.7%) | 0 | Feces discolored | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Feces hard | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Gastrointestinal disorder | 0 | 0 | 1 (2.9%) | 1 (2.9%) | 0 | Groin pain | 0 | 0 | 0 | 0 | 1 (5.6%) | Headache | 0 | 1 (2.9%) | 1 (2.9%) | 2 (5.7%) | 1 (5.6%) | Hypoglycemia | 0 | 0 | 0 | 1 (2.9%) | 1 (5.6%) | Hypokalemia | 0 | 0 | 0 | 0 | 1 (5.6%) | Nasal abscess | 0 | 0 | 0 | 1 (2.9%) | 0 | Nasal congestion | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Nausea | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 | Palpitations | 0 | 0 | 1 (2.95) | 1 (2.9%) | 0 | Pyrexia | 0 | 1 (2.9%) | 1 (2.9%) | 1 (2.9%) | 0 |
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