Skip to main content
. 2021 Mar 12;106(8):1139–1144. doi: 10.1136/bjophthalmol-2020-317560

Table 2.

TEAEs, over 48 weeks

CLS-TA
(N=28)
Control
(N=5)
Total
(N=33)
n (%) of n
subjects events
n (%) of n
subjects events
n (%) of n
subjects events
Any TEAE 19 (67.9) 60 3 (60.0) 8 22 (66.7) 68
 Any TEAE in the Study eye 18 (64.3) 30 3 (60.0) 5 21 (63.6) 35
 Any non-ocular TEAE 4 (14.3) 18 1 (20.0) 2 5 (15.2) 20
Any SAE 1 (3.6) 10 0 1 (3.0) 10
 Any SAE in the Study eye 0 0 0
 Any non-ocular SAE 1 (3.6) 10 0 1 (3.0%) 10
 Deaths 0 0 0
Any on-study TEAE 16 (57.1) 37 3 (60.0) 6 19 (57.6) 43
 Any on-study TEAE in the Study eye 16 (57.1) 20 3 (60.0) 4 19 (57.6) 24
 Any on-study non-ocular TEAE 2 (7.1) 11 1 (20.0) 2 3 (9.1) 13
n (%) of
Subjects
n (%) of
Subjects
n (%) of
Subjects
Any IOP-related event 4 (14.3) 0 4 (12.1)
 IOP increase ≥10 mm Hg 4 (14.3) 0 4 (12.1)
 IOP ≥25 mm Hg 2 (7.1) 0 2 (6.1)
 IOP ≥30 mm Hg 1 (3.6) 0 1 (3.0)
 IOP ≥35 mm Hg 0 0 0
 Use of IOP-lowering medication at crossover visit* 2 (7.1) 0 2 (6.1)
 Use of any additional IOP-lowering medication† 1 (3.6) 0 1 (3.0)
 Surgery for elevated IOP 0 0 0
 Any cataract 7 (25.0) 1 (20.0) 8 (24.2)
 Surgery for cataract 2 (7.1) 0 2 (6.1)

*Includes those medications that started during PEACHTREE and continued into MAGNOLIA.

†Includes those medications that started during MAGNOLIA.

IOP, intraocular pressure; SAE, serious adverse event; TEAEs, treatment-emergent adverse events.