Table 2.
Serious adverse events
| MedDRA lower-level term (n events) |
Treatment recovery period* (n=21) |
3 months† (n=21) |
6 months‡ (n=21) |
12 months§ (n=21) |
24 months¶ (n=20) |
| Worsening dyspnoea | 0 | 0 | 0 | 0 | 1 |
| COPD exacerbation | 0 | 0 | 0 | 1 | 2 |
| Hyponatremia | 1 | 0 | 0 | 0 | 0 |
| Hip fracture | 0 | 0 | 1 | 0 | 0 |
| Pneumonia | 0 | 1 | 1 | 0 | 0 |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 1 |
| Stress cardiomyopathy | 0 | 1 | 0 | 0 | 0 |
| Total | One event in one patient |
Two events in two patients |
Two events in two patients |
One event in one patient |
Four events in two patients |
None were related to investigational device or procedure.
*Defined as the 30 days following either RheOx procedure.
†Defined as the follow-up period through 3 months post treatment 2, excluding the treatment recovery period.
‡Defined as the follow-up period between 3 months and 6 months after treatment 2.
§Defined as the follow-up period between 6 months and 12 months after treatment 2.
¶ Defined as the follow-up period between 12 months and 24 months after treatment 2.
COPD, chronic obstructive pulmonary disease.