Table 4 Adverse events reported by subjects
Adverse events, n (%) | GLY/eFlow 50 μg (N = 29) | GLY/eFlow 50 μg + Charcoal (N = 29) | GLY/DPI 63 μg (N = 28) | GLY/DPI 63 μg + Charcoal (N = 27) | IV Infusion 50 μg (N = 27) |
|---|---|---|---|---|---|
Any AE | 6 (20.7) | 9 (31.0) | 7 (25.0) | 11 (40.7) | 7 (25.9) |
Ear and labyrinth disorders | 1 (3.4) | 1 (3.4) | 0 | 0 | 0 |
Cerumen impaction | 1 (3.4) | 0 | 0 | 0 | 0 |
Ear pain | 0 | 1 (3.4) | 0 | 0 | 0 |
Gastrointestinal disorders | 1 (3.4) | 3 (10.3) | 0 | 3 (11.1) | 0 |
Abdominal discomfort | 0 | 0 | 0 | 1 (3.7) | 0 |
Abdominal pain | 0 | 2 (6.9) | 0 | 0 | 0 |
Dry mouth | 0 | 0 | 0 | 1 (3.7) | 0 |
Nausea | 0 | 1 (3.4) | 0 | 0 | 0 |
Toothache | 1 (3.4) | 0 | 0 | 1 (3.7) | 0 |
Vomiting | 0 | 1 (3.4) | 0 | 0 | 0 |
General disorders and administration site conditions | 1 (3.4) | 0 | 2 (7.1) | 2 (7.4) | 0 |
Catheter site hematoma | 0 | 0 | 0 | 1 (3.7) | 0 |
Catheter site pain | 0 | 0 | 1 (3.6) | 1 (3.7) | 0 |
Influenza like illness | 1 (3.4) | 0 | 0 | 0 | 0 |
Malaise | 0 | 0 | 0 | 1 (3.7 | 0 |
Vessel puncture site hematoma | 0 | 0 | 1 (3.6) | 0 | 0 |
Infections and infestations | 0 | 2 (6.9) | 1 (3.6) | 0 | 1 (3.7) |
Ear infection | 0 | 0 | 1 (3.6) | 0 | 0 |
Gastroenteritis | 0 | 1 (3.4) | 0 | 0 | 0 |
Influenza | 0 | 0 | 0 | 0 | 1 (3.7) |
Nasopharyngitis | 0 | 1 (3.4) | 0 | 0 | 0 |
Musculoskeletal and connective tissue disorders | 1 (3.4) | 0 | 2 (7.1)0 | 1 (3.7)0 | 0 |
Back pain | 0 | 0 | 2 (7.1) | 1 (3.7) | 0 |
Musculoskeletal discomfort | 1 (3.4) | 0 | 0 | 0 | 0 |
Nervous system disorders | 1 (3.4) | 4 (13.8) | 1 (3.6) | 4 (14.8) | 4 (14.8) |
Headache | 1 (3.4) | 3 (10.3) | 1 (3.6) | 4 (14.8) | 4 (14.8) |
Migraine | 0 | 1 (3.4) | 0 | 0 | 0 |
Psychiatric disorders | 0 | 0 | 0 | 0 | 1 (3.7) |
Panic attack | 0 | 0 | 0 | 0 | 1 (3.7) |
Respiratory, thoracic and mediastinal disorders | 1 (3.4) | 1 (3.4) | 2 (7.1) | 1 (3.7) | 1 (3.7) |
Cough | 1 (3.4) | 1 (3.4) | 0 | 0 | 0 |
Dry throat | 0 | 0 | 1 (3.6) | 0 | 1 (3.7) |
Dyspnea | 0 | 0 | 0 | 1 (3.7) | 0 |
Oropharyngeal pain | 0 | 0 | 1 (3.6) | 0 | 0 |
Skin and subcutaneous tissue disorders | 1 (3.4) | 1 (3.4) | 0 | 0 | 0 |
Ecchymosis | 1 (3.4) | 1 (3.4) | 0 | 0 | 0 |
Vascular disorders | 0 | 0 | 0 | 1 (3.7) | 1 (3.7) |
Hypertension | 0 | 0 | 0 | 1 (3.7) | 0 |
Phlebitis | 0 | 0 | 0 | 0 | 1 (3.7) |