Henrotin et al. BMC Musculoskeletal Disorders
(2022) 23:650
Page 8 of 11
Fig. 3 Time evolution of VAS pain in the participant of the ITT population with a Body Mass Index (BMI) > to 25. * = significant effect of RIE compared to placebo
Fig. 4 Percentage of participants of the ITT population responding to treatment according to OMERACT-OARSI criteria. * = significant effect of RIE compared to placebo
and eight participants (12.1%) in the RIE 400 mg who reported ≥ 1 AEs possibly-related-to-product. Only one participant in each active product group had reported two possibly-related-to-product AEs. Eight (33.3%) of the possibly-related-to-product AEs ( N = 24) were due to elevated blood results requiring General Practitioner follow-up reported by eight participants ( N = 2 Pla- cebo; N = 4 RIE 200 mg group; N = 2 RIE 400 mg group). Twelve (50.0%) possibly-related-to-product AEs ( N = 24)
(39.4%) in the RIE 400 mg, who reported ≥ 1 AE(s). How- ever, there were only 22 participants (10.8%) with ≥ 1 AEs possibly-related-to-product in the Safety Population ( N = 203) who reported a total of 24 AEs possibly-related- to-product. All other AEs reported were identified as not related-to-product. There were four participants (5.9%) in the placebo group who reported 1 AE possibly-related -to-product, ten participants (14.5%) in the RIE 200 mg group who reported ≥ 1 AEs possibly-related-to-product,
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