Restoring Study PRGF: a randomized clinical trial on plasma rich in growth factors for knee osteoarthritis

Table 5 Adverse events registered in the clinical trial

Safety outcomes	PRGF		HA	Proportion mean difference (95% CI)	p value
Safety outcomes	n/N (%)			Proportion mean difference (95% CI)	p value
Total AE^a	PP analysis	26/79 (32.9%)	24/74 (32.4%)	0.5% (−14.4 to 15.3)	0.950
Total AE^a	ITT analysis	26/89 (29.2%)	24/87 (27.6%)	1.6% (−11.7 to 14.9)	0.811
Serious or unexpected AE^b	1/26 (3.8%)		1/24 (4.2%)	---	---
Total persistent AE ^c	5/26 (19.2%)		2/24 (8.3%)	---	---
Total AE by Ahlbäck grade:				---	---
Grade 1	17/26 (65.4%)		12/24 (50%)
Grade 2	4/26 (15.4%)		11/24 (45.8%)
Grade 3	4/26 (15.4%)		1/24 (4.2%)
Grade 4	1/26 (3.8%)		0/24 (0.0%)
Total AE by relation to treatment:				---	---
Unrelated	25/26 (96.2%)		22/24 (91.6%)
Possible	0/26 (0.0%)		1/24 (4.2%)
Highly likely	1/26 (3.8%)		1/24 (4.2%)

AE adverse event, HA hyaluronic acid, ITT intention-to-treat, PP per-protocol, PRGF plasma rich in growth factors
^aProportion mean differences for the outcome ‘Total AE’ have been calculated and presented using the raw data provided by the final report
^bThere were registered one participant with a knee trauma event during the study in the PRGF group and one participant with a non-specific trauma event in the HA group
^cThere were registered four participants with knee pain and one participant with shoulder pain in the PRGF group. One participant with knee pain and one participant with knee and hip pain were registered in the HA group

ISSN: 1745-6215