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Clinical Trial Report

Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis

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Pages 2519-2534 | Published online: 06 Dec 2018

Figures & data

Figure 1 Patient disposition stratified by indication, history of DEX use, and number of on-study DEX injections.

Notes: Study completion rates and reasons for discontinuations are shown for the ATP population. Patient disposition data were missing for five patients in the ATP population; that is, five patients with RVO in the ATP population had no end-of-study form and are not counted as having completed or discontinued the study.
Abbreviations: ATP, according to protocol; DEX, dexamethasone intravitreal implant; NIPSU, noninfectious posterior segment uveitis; RVO, retinal vein occlusion.
Figure 1 Patient disposition stratified by indication, history of DEX use, and number of on-study DEX injections.

Table 1 Baseline patient characteristics (ATP population)

Table 2 Baseline characteristics of treated eyes (ATP population)

Table 3 Medical and ocular histories of patients at baseline (ATP population)

Table 4 Nonocular serious adverse events classified by primary system organ class in all patients and stratifications (ATP population)

Table 5 Ocular serious adverse events in all treated eyes and stratifications (ATP population)

Table 6 Adverse events of special interest in all treated eyes and stratifications (ATP population)

Table 7 Ocular procedures performed during the study in two or more treated eyes (ATP population)

Table S1 Incidence rates of ocular serious adverse events per person-year in all treated eyes and in treated eyes stratified by indication (ATP population)

Table S2 Incidence rates of adverse events of special interest per person-year in all treated eyes and in treated eyes stratified by indication (ATP population)