Table 4—

Adverse events

Subjects860
Serious adverse events415 (48)
 Heart failure122 (14)
 Pulmonary hypertension76 (9)
 Syncope38 (4)
 Pneumnoia37 (4)
 Dyspnoea28 (3)
Serious adverse events attributable to treprostinil62 (7)
 Site infection9 (1)
 Systemic hypotension8 (1)
 Site pain7 (1)
 Dyspnoea4 (<1)
 Syncope4 (<1)
 Heart failure4 (<1)
Adverse events
 Infusion site pain792 (92)
 Site reaction700 (81)
 Bleeding/bruising170 (20)
 Infection35 (4)
Treatment-related events
 Headache15 (2)
 Pain12 (1)
 Diarrhoea11 (1)
 Nausea10 (1)
Treatment-related events leading to dose reduction
 Diarrhoea57 (7)
 Headache54 (6)
 Nausea53 (6)
 Vomiting23 (3)
 Pain21 (2)
 Vasodilatation21 (2)
 Dizziness20 (2)
 Jaw Pain15 (2)
 Systemic hypotension14 (2)
 Anorexia9 (1)
Prostacyclin-related effects
 Diarrhoea365 (42)
 Nausea235 (27)
 Headache214 (25)
 Jaw pain195 (23)
 Pain139 (16)
 Vasodilation115 (13)
 Anorexia89 (10)
 Rash88 (10)
Delivery system complications255 (30)
 Pump malfunction222 (26)
 Infusion set complications74 (9)
Overdose
 Programming error3 (<1)
 Accidental bolus4 (<1)
 Concentration increase without rate decrease6 (1)
 Infusion set replacement following catheter dislodgement1 (<1)
Haemorrhagic events
 Epistaxis14 (2)
 Ecchymosis11 (1)
 Haemoptysis10 (1)
 Haemorrhage1 (<1)
 Thrombocytopenia6 (1)
 Thrombocytopenia-related hospitalisation1 (<1)
 Severe thrombocytopenia2 (<1)
Renal failure12 (1)
Hepatic failure3 (<1)
  • Data are presented as n or n (%).