Table 3.

Adverse events and serious adverse events (SAEs)

Study number	Cohort	Adverse event	Grade	Day	Action	Relationship to treatment	Relationship to procedure
1	1×106 tolDC	Discomfort right heel	Mild	0	Nil	Unrelated	Probable (secondary to immobilisation)
1	1×106 tolDC	Redness right heel	Mild	0	Nil	Unrelated	Probable (secondary to immobilisation)
1	1×106 tolDC	Bruising below knee	Mild	1	Nil	Unrelated	Related to arthroscopy
1	1×106 tolDC	Target knee synovitis	Moderate	10	Aspiration d10, IA glucocorticoid d14	Possible	Unrelated
1	1×106 tolDC	Wound infection target knee	Mild	31	Oral flucloxacillin	Unlikely	Related to arthroscopy
2	Control	Leg cramps	Mild	≈14	Quinine sulfate	Unrelated	Unlikely
3	1×106 tolDC	Iron deficiency anaemia	Moderate	−14	Ferrous sulfate	Unrelated	Unrelated
3	1×106 tolDC	Citrate Toxicity	Mild	−7	Nil	Unrelated	Related to leucapheresis
3	1×106 tolDC	Increased target knee pain	Moderate	0	Analgesia	Unlikely	Related to arthroscopy
3	1×106 tolDC	Fatigue	Mild	1	Nil	Unlikely	Possible
3	1×106 tolDC	General RA flare	Moderate	9	IM glucocorticoid	Possible	Unrelated
3	1×106 tolDC	General RA flare	N/A (SAE)	70	Hospitalised, commenced tocilizumab	Unlikely	Unrelated
3	1×106 tolDC	Pneumonia	N/A (SAE)	85	Hospitalised, antibiotics	Unlikely	Unrelated
4	1×106 tolDC	Increased stiffness of target knee	Moderate	1	Nil	Unlikely	Possible
4	1×106 tolDC	New patch of psoriasis on forearm	Mild	6	Topical steroid/calcipitriol	Possible	Unrelated
4	1×106 tolDC	Increased pain both knees	Mild	6	Nil	Possible	Unrelated
5	3×106 tolDC	Flare IA	Mild	−7	Nil	Unrelated	Unrelated
5	3×106 tolDC	Rhinorrhoea	Mild	3	Nil	Possible	Unrelated
5	3×106 tolDC	Target knee synovitis	Moderate	10	Aspirated, naproxen dose ↑	Possible	Unrelated
5	3×106 tolDC	Eczema right elbow	Mild	57	Topical hydrocortisone	Unlikely	Unrelated
6	Control	Rash right forearm	Mild	−7	Nil	Unrelated	Unrelated
6	Control	Upper respiratory tract infection	Mild	44	Oral amoxicillin	Unrelated	Unrelated
7	3×106 tolDC	Increased stiffness in target knee	Mild	9	Ibuprofen	Possible	Unrelated
8*		Wound infection	Mild	2	Oral flucloxacillin	Unrelated	Related to arthroscopy
9	3×106 tolDC	Non-target knee synovitis	Moderate	0	Ibuprofen	Unrelated	Unrelated
9	3×106 tolDC	Fatigue	Mild	4	Nil	Possible	Unrelated
9	3×106 tolDC	Elevated C reactive protein and bilateral knee synovitits	Moderate	7	IA glucocorticoid	Possible	Unrelated
9	3×106 tolDC	Fatigue	Mild	10	Nil	Possible	Unrelated
9	3×106 tolDC	Fluid leak from target knee wound	Mild	21	Oral flucloxacillin	Unrelated	Related to arthroscopy
10	10×106 tolDC	Increased target knee pain after long walk	Mild	6	Nil	Possible	Unrelated
10	10×106 tolDC	Worsening psoriasis bottom of feet	Mild	55	Topical calcipitriol	Possible	Unrelated
10	10×106 tolDC	Arthralgia due to osteoarthritis	Mild	≈60	Nil	Unrelated	Unrelated
11	Control	Iron deficiency anaemia	Moderate	≈11	Ferrous gluconate	Unlikely	Possible
11	Control	Rhinorrhoea	Mild	13	Nil	Unrelated	Unrelated
13	10×106 tolDC	Vasovagal episode	Mild	0	Nil	Unrelated	Related to arthroscopy
13	10×106 tolDC	Upper respiratory tract infection	Mild	11	Paracetamol	Possible	Unrelated
13	10×106 tolDC	General stiffness and discomfort	Mild	23	Nil	Possible	Unrelated
13	10×106 tolDC	Folliculitis	Mild	28	Nil	Possible	Unrelated
13	10×106 tolDC	Swelling non-target knee with effusion	Mild	84	IA glucocorticoid	Unlikely	Unrelated

*Cells from study number (participant) 8 did not meet QC release criteria, see table 1.

IA, intra-articular; IM, intra-muscular; N/A, not applicable; RA, rheumatoid arthritis; tolDC, tolerogenic dendritic cells.