A feasibility and safety study of afamelanotide in acute stroke patients – an open label, proof of concept, phase iia clinical trial

Table 1 Baseline demographics and adverse outcomes

Patient	Age	Sex	Stroke territory	Exclusions for acute treatment	Aetiology	Baseline NIHSS	Baseline mRS	Adverse outcomes¹ (up to D9)
1	84	F	Left MCA	Recent hip surgery Distal clot migration	Cardioembolic	6	2	Nil
2	86	F	Left MCA	Onset > 4.5 h, on therapeutic anticoagulation Distal M2 occlusion	Cardioembolic	7	0	UTI, constipation, agitation
3	79	F	Left PCA & Right MCA	Recent hip surgery P2 occlusion	Cardioembolic	9	1	Haemorrhagic transformation (PH1), troponin rise, fluid overload
4	74	M	Left MCA	Fluctuating symptoms M2 occlusion	LAA	4	0	Nausea, loss of appetite, ankle pain, constipation
5	83	F	Left MCA	Unclear time of onset Unfavourable mismatch ratio	ESUS	5	0	Delirium
6	50	F	Left MCA	Onset > 4.5 h M2 occlusion	LAA	1	0	Recurrent stroke on D5, possible UTI, fatal haemorrhagic transformation on D9

¹ Assessed as unrelated to afamelanotide. MCA – middle cerebral artery; PCA – posterior cerebral artery; LAA – large arterial atherosclerosis; ESUS – embolic strokes of unknown source; UTI – urinary tract infection; PH1 – Parenchymal haematoma 1

ISSN: 1471-2377