Table 5.
Adverse reaction features.
Characteristic | Prostanoid-naïve n = 6 (21.4%) | Transition n = 22 (78.6%) | Overall n = 28 |
---|---|---|---|
Patients with adverse reaction | 5 (83.3) | 16 (72.7) | 21 (75.0) |
Adverse events (n) | 22 | 59 | 81 |
Adverse reaction severity | |||
Mild | 6 (27.3) | 16 (27.1) | 22 (27.1) |
Moderate | 12 (54.6) | 27 (45.8) | 39 (48.1) |
Severe | 3 (13.6) | 16 (27.1) | 19 (23.5) |
Not defined | 1 (4.5) | 0 (0.0) | 1 (1.3) |
Timing of symptom | |||
Immediately | 1 (4.5) | 4 (6.8) | 5 (6.2) |
Days | 4 (18.2) | 24 (40.8) | 28 (34.6) |
Weeks | 5 (22.8) | 20 (33.8) | 25 (30.7) |
Months | 9 (40.9) | 11 (18.6) | 20 (24.6) |
Years | 2 (9.1) | 0 (0.0) | 2 (2.6) |
Not defined | 1 (4.5) | 0 (0.0) | 1 (1.3) |
Symptom setting | |||
Dose increase | 11 (50.0) | 6 (10.2) | 17 (21.0) |
Initiation/transition only | 2 (9.1) | 6 (10.2) | 8 (10.0) |
Initiation/transition/ maintenance | 0 (0.0) | 23 (39.0) | 23 (28.4) |
Maintenance only | 4 (18.2) | 16 (27.1) | 20 (24.6) |
Other | 5 (22.7) | 8 (13.5) | 13 (16.0) |
Symptom duration | |||
Transient | 16 (72.7) | 34 (57.6) | 50 (61.7) |
Persistent | 6 (27.3) | 23 (39.0) | 29 (35.8) |
Other | 0 (0.0) | 2 (3.4) | 2 (2.6) |
Symptom resolution | |||
Partial | 3 (13.6) | 20 (33.9) | 23 (28.5) |
Complete | 13 (59.2) | 21 (35.6) | 34 (41.9) |
Not defined | 6 (27.2) | 18 (30.5) | 24 (29.6) |
Management | |||
No change | 11 (50) | 24 (40.8) | 35 (43.3) |
Dose lowered | 3 (13.6) | 13 (22.0) | 16 (19.8) |
Uptitration rate slowed | 7 (31.9) | 15 (25.4) | 22 (27.1) |
Discontinued treprostinil (patients) | 1 (16.7) | 4 (9.1) | 5 (17.9) |
Values are given as n (%).
The percent noted relates to the number of adverse reactions, not the number of patients affected except for “Patients with adverse reactions” and “Discontinued treprostinil,” which report the number of patients.
Adverse reactions that occurred during initial study period through 1 June 2017; includes initiation, transition, and maintenance.