Table 2.
Group A (n=107) |
Group B (n=104) |
||
Any TEAEa,b | 42 (39.3) | 38 (36.5) | |
Any TEAE occurring in ≥2% of patients | |||
Arthralgia | 8 (7.5) | 12 (11.5) | |
Upper respiratory tract infection | 7 (6.5) | 2 (1.9) | |
Any serious TEAEsc | 5 (4.7) | 1 (1.0) | |
Any TEAE leading to death | 0 | 0 | |
Any TEAE leading to discontinuation of Jawboned | 1 (0.9) | 0 | |
Any TEAE leading to discontinuation of OA GOd,e | 1 (0.9) | — |
aTEAE: treatment-emergent adverse events.
bAll TEAEs were mild to moderate in severity.
cSerious AEs included upper respiratory tract infection, transient ischemic attack, large intestine perforation, arthralgia and worsening OA, each in one patient in Group A and cholecystitis in one patient in Group B.
dSame patient discontinued both devices; the TEAE leading to discontinuation was worsening OA.
eOA: osteoarthritis.