The following serious adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of VELSIPITY 2 mg once daily in subjects with moderately to severely active ulcerative colitis was evaluated in two randomized, placebo-controlled studies of 52 weeks (UC-1) and 12 weeks (UC-2) duration [see Clinical Studies (14)]. Additional safety data were obtained from a randomized, double-blind, placebo-controlled dose-finding study of 12 weeks duration (UC-3).
In the 52-week study (UC-1), 433 subjects were enrolled of whom 289 received VELSIPITY 2 mg once daily. In the 12-week studies (UC-2 and UC-3), 458 subjects were enrolled of whom 288 received VELSIPITY 2 mg once daily.
Table 1 summarizes the adverse reactions reported in at least 2% of subjects and at a higher rate than placebo during UC-1.
| ||
Adverse Reaction | VELSIPITY 2 mg Once Daily N = 289 % | Placebo N = 144 % |
Headache† | 9 | 5 |
Elevated liver tests‡ | 6 | 5 |
Dizziness§ | 5 | 2 |
Arthralgia | 4 | 2 |
Hypertension¶ | 3 | 1 |
Urinary tract infection# | 3 | 2 |
Nausea | 3 | 1 |
HypercholesterolemiaÞ | 3 | 0 |
Herpes viral infectionß | 2 | 1 |
Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher rate than placebo during UC-2 and UC-3.
| ||
Adverse Reaction | VELSIPITY 2 mg Once Daily N = 288 %† | Placebo N = 170 %† |
Headache‡ | 6 | 4 |
Elevated liver tests§ | 5 | <1 |
Nausea | 4 | 2 |
Bradycardia¶ | 3 | 0 |
Urinary tract infection# | 3 | 0 |
Ophthalmologic Findings
In UC-1, for subjects with a baseline and follow-up examination, a decrease in visual acuity was reported in 2.6% (4/156) of subjects who received VELSIPITY and no subjects who received placebo [see Warnings and Precautions (5.4)].
The following serious adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of VELSIPITY 2 mg once daily in subjects with moderately to severely active ulcerative colitis was evaluated in two randomized, placebo-controlled studies of 52 weeks (UC-1) and 12 weeks (UC-2) duration [see Clinical Studies (14)]. Additional safety data were obtained from a randomized, double-blind, placebo-controlled dose-finding study of 12 weeks duration (UC-3).
In the 52-week study (UC-1), 433 subjects were enrolled of whom 289 received VELSIPITY 2 mg once daily. In the 12-week studies (UC-2 and UC-3), 458 subjects were enrolled of whom 288 received VELSIPITY 2 mg once daily.
Table 1 summarizes the adverse reactions reported in at least 2% of subjects and at a higher rate than placebo during UC-1.
| ||
Adverse Reaction | VELSIPITY 2 mg Once Daily N = 289 % | Placebo N = 144 % |
Headache† | 9 | 5 |
Elevated liver tests‡ | 6 | 5 |
Dizziness§ | 5 | 2 |
Arthralgia | 4 | 2 |
Hypertension¶ | 3 | 1 |
Urinary tract infection# | 3 | 2 |
Nausea | 3 | 1 |
HypercholesterolemiaÞ | 3 | 0 |
Herpes viral infectionß | 2 | 1 |
Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher rate than placebo during UC-2 and UC-3.
| ||
Adverse Reaction | VELSIPITY 2 mg Once Daily N = 288 %† | Placebo N = 170 %† |
Headache‡ | 6 | 4 |
Elevated liver tests§ | 5 | <1 |
Nausea | 4 | 2 |
Bradycardia¶ | 3 | 0 |
Urinary tract infection# | 3 | 0 |
Ophthalmologic Findings
In UC-1, for subjects with a baseline and follow-up examination, a decrease in visual acuity was reported in 2.6% (4/156) of subjects who received VELSIPITY and no subjects who received placebo [see Warnings and Precautions (5.4)].
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