Table S5.
Device-related adverse events*—number of patients reporting AEs (ITT analysis) (Patients may report more than 1 AE)
| EPAP | Sham | |
|---|---|---|
| N = 119 | N = 110 | |
| Respiratory, thoracic and mediastinal disorders | 25 (21.0%) | 22 (20.0%) |
| Nasal congestion | 10 (8.4%) | 5 (4.5%) |
| Nasal discomfort | 9 (7.6%) | 13 (11.8%) |
| Cough | 2 (1.7%) | 0 (0.0%) |
| Nasal dryness | 1 (0.8%) | 0 (0.0%) |
| Oropharyngeal pain | 1 (0.8%) | 0 (0.0%) |
| Rhinorrhea (discharge of nasal mucus) | 1 (0.8%) | 1 (0.9%) |
| Sinusitis | 1 (0.8%) | 1 (0.9%) |
| Snoring | 1 (0.8%) | 0 (0.0%) |
| Suffocation feeling | 1 (0.8%) | 0 (0.0%) |
| Dyspnea (shortness of breath) | 0 (0.0%) | 2 (1.8%) |
| Epistaxis (nosebleed) | 0 (0.0%) | 2 (1.8%) |
| Productive cough | 0 (0.0%) | 1 (0.9%) |
| Sinus congestion | 0 (0.0%) | 1 (0.9%) |
| Upper respiratory infection | 0 (0.0%) | 1 (0.9%) |
| Nervous system disorders | 16 (13.4%) | 10 (9.1%) |
| Insomnia | 5 (4.2%) | 1 (0.9%) |
| Headache | 5 (4.2%) | 5 (4.5%) |
| Initial insomnia | 4 (3.4%) | 2 (1.8%) |
| Poor quality sleep | 2 (1.7%) | 0 (0.0%) |
| Drooling | 2 (1.7%) | 0 (0.0%) |
| Somnolence (sleepiness) | 1 (0.8%) | 3 (2.7%) |
| Vertigo | 1 (0.8%) | 0 (0.0%) |
| Abnormal dreams | 0 (0.0%) | 2 (1.8%) |
| Dizziness | 0 (0.0%) | 1 (0.9%) |
| Gastrointestinal disorders | 18 (15.1%) | 3 (2.7%) |
| Dry mouth | 13 (10.9%) | 3 (2.7%) |
| Dry throat | 4 (3.4%) | 0 (0.0%) |
| Chapped lips | 1 (0.8%) | 0 (0.0%) |
| Dysgeusia (dysfunction of sense of taste) | 1 (0.8%) | 0 (0.0%) |
| Dry lips | 1 (0.8%) | 0 (0.0%) |
| Injury, poisoning, and procedural complications | 18 (15.1%) | 7 (6.4%) |
| Device interaction (exhalation difficulty, discomfort with device) | 17 (14.3%) | 4 (3.6%) |
| Medical device site reaction (moisture in nose behind device) | 2 (1.7%) | 0 (0.0%) |
| Instillation site pain (nostril soreness) | 0 (0.0%) | 3 (2.7%) |
| Psychiatric disorders | 2 (1.7%) | 3 (2.7%) |
| Anxiety | 2 (1.7%) | 3 (2.7%) |
| Eye disorders | 1 (0.8%) | 0 (0.0%) |
| Lacrimation increased (tear production) | 1 (0.8%) | 0 (0.0%) |
| Investigations | 1 (0.8%) | 1 (0.9%) |
| Blood pressure increased | 1 (0.8%) | 0 (0.0%) |
| Oxygen saturation decreased | 0 (0.0%) | 1 (0.9%) |
| Skin and subcutaneous tissue disorders | 1 (0.8%) | 0 (0.0%) |
| Dermatitis | 1 (0.8%) | 0 (0.0%) |
| Vascular disorders | 1 (0.8%) | 0 (0.0%) |
| Worsening hypertension | 1 (0.8%) | 0 (0.0%) |
| Cardiac disorders | 0 (0.0%) | 1 (0.9%) |
| Worsening of coronary artery disease | 0 (0.0%) | 1 (0.9%) |
*
Device-related adverse events were categorized using MedDRA coding. MedDRA, the Medical Dictionary for Regulatory Activities terminology, is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).