Trial Outcomes & Findings for A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) (NCT NCT03283085)
NCT ID: NCT03283085
Last Updated: 2024-06-21
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
557 participants
Primary outcome timeframe
From first dose of study drug up to end of study [EOS] (up to 5.79 years)
Results posted on
2024-06-21
Participant Flow
Participants took part in the study at 225 investigative sites in 33 countries from 27 February 2018 to 13 December 2023.
Participants from induction and maintenance studies of ulcerative colitis (UC) \[SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and SHP647-303 (NCT03290781)\] and Crohn's disease (CD) \[SHP647-305 (NCT03559517), SHP647-306 (NCT03566823), and SHP647-307 (NCT03627091)\] were enrolled to receive either 25 milligrams (mg) or 75 mg ontamalimab.
Participant milestones
| Measure |
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
159
|
268
|
5
|
10
|
26
|
|
Overall Study
COMPLETED
|
0
|
117
|
129
|
0
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
89
|
42
|
139
|
5
|
4
|
14
|
Reasons for withdrawal
| Measure |
UC: Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
18
|
3
|
13
|
0
|
0
|
5
|
|
Overall Study
Death
|
0
|
0
|
3
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
42
|
21
|
66
|
3
|
3
|
5
|
|
Overall Study
Physician Decision
|
14
|
8
|
19
|
0
|
0
|
2
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
12
|
6
|
24
|
1
|
1
|
0
|
|
Overall Study
Reason not Specified
|
0
|
4
|
8
|
0
|
0
|
1
|
Baseline Characteristics
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Baseline characteristics by cohort
| Measure |
UC: Ontamalimab 25 mg
n=89 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=159 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
n=268 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
Total
n=557 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=93 Participants
|
148 Participants
n=4 Participants
|
239 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
25 Participants
n=10 Participants
|
512 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
227 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
92 Participants
n=4 Participants
|
157 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
330 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=93 Participants
|
146 Participants
n=4 Participants
|
251 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
519 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=93 Participants
|
135 Participants
n=4 Participants
|
231 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
479 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to end of study [EOS] (up to 5.79 years)Population: The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=89 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=159 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
n=268 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
67 Participants
|
122 Participants
|
203 Participants
|
4 Participants
|
8 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to EOS (up to 5.79 years)Population: The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment.
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=89 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=159 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
n=268 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Infections
|
5 Participants
|
4 Participants
|
17 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to EOS (up to 5.79 years)Population: The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported.
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=89 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=159 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
n=268 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: From first dose of study drug up to EOS (up to 5.79 years)Population: The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported.
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=89 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=159 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
n=268 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: From first dose of study drug up to EOS (up to 5.79 years)Population: The Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=89 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=159 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
n=268 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 Participants
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Discernible Changes in Vital Signs Over Time
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 5.79 yearsPopulation: Full Analysis Set (FAS) included all participants in the randomized set who received at least 1 dose of IP in the SHP647-304 study. Overall number analyzed is the number of UC participants with data available for analyses.
Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=120 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=133 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Ulcerative Colitis With Treatment Response Over Time
|
116 Participants
|
129 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5.79 yearsPopulation: FAS included all participants in randomized set who received at least 1 dose of IP in the SHP647-304 study. With implementation of protocol amendment 4 this became a single arm study with all participants receiving 75 mg ontamalimab. Hence, only those CD participants who were receiving ontamalimab 75mg Q4W and participating in amendment 4 of the protocol were analyzed. Overall number analyzed is the number of CD participants with data available for analyses.
Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence \& size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;\>2cm=3);extent of ulcerated surface(none=0;\<10%=1;10%-30%=2; \>30%= 3);extent of affected surface(none=0;\<50%=1;50%-75%=2;\>75%=3);Presence \& type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3).
Outcome measures
| Measure |
UC: Ontamalimab 25 mg
n=6 Participants
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
|
UC: Ontamalimab 25 mg Then 75 mg
n=13 Participants
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
CD: Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Crohn's Disease With Treatment Response Over Time
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
UC: Ontamalimab 25 mg
Serious events: 15 serious events
Other events: 47 other events
Deaths: 0 deaths
UC: Ontamalimab 25mg Then 75 mg
Serious events: 21 serious events
Other events: 109 other events
Deaths: 0 deaths
UC: Ontamalimab 75mg
Serious events: 46 serious events
Other events: 155 other events
Deaths: 3 deaths
CD: Ontamalimab 25 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
CD: Ontamalimab 25 mg Then 75 mg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
CD: Ontamalimab 75 mg
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UC: Ontamalimab 25 mg
n=89 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
UC: Ontamalimab 25mg Then 75 mg
n=159 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75mg
n=268 participants at risk
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, forup to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 participants at risk
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
General disorders
Chest pain
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
6.7%
6/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
3/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.7%
10/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Colon dysplasia
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.75%
2/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Cytomegalovirus gastrointestinal infection
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
General disorders
Death
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Infection
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Perirectal abscess
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.1%
3/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Pneumonia viral
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.1%
3/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.75%
2/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Subcutaneous abscess
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Eye disorders
Uveitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
Other adverse events
| Measure |
UC: Ontamalimab 25 mg
n=89 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
UC: Ontamalimab 25mg Then 75 mg
n=159 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 3 years.Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
UC: Ontamalimab 75mg
n=268 participants at risk
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, forup to 5.79 years.
|
CD: Ontamalimab 25 mg
n=5 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
|
CD: Ontamalimab 25 mg Then 75 mg
n=10 participants at risk
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
|
CD: Ontamalimab 75 mg
n=26 participants at risk
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
2/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.9%
11/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.0%
8/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
7.7%
2/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.9%
7/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
8.8%
14/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.0%
16/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Anal fistula
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
11.5%
3/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
3/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.3%
10/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
4.9%
13/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
2/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis enteropathic
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.9%
11/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.7%
10/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
2/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
5.7%
9/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.0%
8/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
2/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.1%
3/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
24.7%
22/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
13.2%
21/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.4%
28/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.1%
3/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Corona virus infection
|
2.2%
2/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
25.2%
40/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
21.3%
57/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
2/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
15.4%
4/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
11.5%
3/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Dental caries
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
3/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.7%
17/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.7%
10/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
7.7%
2/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
3/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
5/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
2/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.3%
10/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.4%
9/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Eye disorders
Eyelid rash
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
3/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
5.0%
8/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
2.2%
6/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Nervous system disorders
Headache
|
3.4%
3/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.1%
16/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.7%
10/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
1/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
11.5%
3/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Vascular disorders
Hypertension
|
3.4%
3/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
7.5%
12/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
4.9%
13/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Influenza
|
2.2%
2/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.1%
5/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.0%
16/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Psychiatric disorders
Insomnia
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.0%
8/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.63%
1/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
7.7%
2/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
2/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
11.3%
18/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
7.5%
20/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
11.5%
3/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.9%
11/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
5/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.37%
1/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
5.7%
9/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
5/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
2.5%
4/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Pharyngitis
|
3.4%
3/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.4%
9/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
General disorders
Pyrexia
|
4.5%
4/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
5.7%
9/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
4.9%
13/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Respiratory tract infection
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
2.5%
4/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.1%
1/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.9%
3/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
2/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Immune system disorders
Rubber sensitivity
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
6/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.5%
4/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
20.0%
2/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
1.3%
2/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
3/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
5.7%
9/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
6.0%
16/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
3.8%
1/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Eye disorders
Uveitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/89 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/159 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.75%
2/268 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/5 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
10.0%
1/10 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
0.00%
0/26 • From first dose of study drug up to EOS (up to 5.79 years)
Safety Set included all participants who received at least 1 dose of IP in the SHP647-304 study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place