Trial Outcomes & Findings for TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) (NCT NCT01903252)
NCT ID: NCT01903252
Last Updated: 2018-08-08
Results Overview
Mayo Score of \<= 2 points with no individual sub-score \> 1
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
817 participants
Primary outcome timeframe
Week 8
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
TP05 (Mesalazine) 1600 mg
3.2g/day once daily (OD) for 12 weeks (blinded),
|
Asacol (Mesalazine 400 mg)
3.2g/d twice daily for 12 weeks (blinded),
|
Extended Induction
Non-responders at week 8 of the induction phase were taken out of the double-blind phase and treated with TP05 4.8g/day OD for another 8 weeks
|
1.6g TP05 (1600 mg) /Day Maintenance Open-Label
Remitters at week 12 of the induction phase received a daily dose of 1.6g OD in the maintenance phase open-label.
|
3.2g TP05 (1600 mg) /Day Maintenance Open-Label
Responders at week 12 of the induction phase remained on a daily dose of 3.2 g OD in the maintenance phase open-label.
|
4.8g TP05 (1600 mg) /Day Maintenance Open-Label
Non-responders at week 12 of the double-blind induction phase as well as non-responders at week 8 of the induction phase who responded after a second 8 weeks of extended induction treatments, were enrolled into the maintenance phase and remained on a daily dose of 4.8g OD.
|
|---|---|---|---|---|---|---|
|
Double-Blind Induction
STARTED
|
409
|
408
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction
COMPLETED
|
370
|
367
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction
NOT COMPLETED
|
39
|
41
|
0
|
0
|
0
|
0
|
|
Extended Induction, Open-Label
STARTED
|
0
|
0
|
243
|
0
|
0
|
0
|
|
Extended Induction, Open-Label
COMPLETED
|
0
|
0
|
220
|
0
|
0
|
0
|
|
Extended Induction, Open-Label
NOT COMPLETED
|
0
|
0
|
23
|
0
|
0
|
0
|
|
Maintenance, Open-Label
STARTED
|
0
|
0
|
0
|
202
|
274
|
199
|
|
Maintenance, Open-Label
COMPLETED
|
0
|
0
|
0
|
196
|
253
|
181
|
|
Maintenance, Open-Label
NOT COMPLETED
|
0
|
0
|
0
|
6
|
21
|
18
|
Reasons for withdrawal
| Measure |
TP05 (Mesalazine) 1600 mg
3.2g/day once daily (OD) for 12 weeks (blinded),
|
Asacol (Mesalazine 400 mg)
3.2g/d twice daily for 12 weeks (blinded),
|
Extended Induction
Non-responders at week 8 of the induction phase were taken out of the double-blind phase and treated with TP05 4.8g/day OD for another 8 weeks
|
1.6g TP05 (1600 mg) /Day Maintenance Open-Label
Remitters at week 12 of the induction phase received a daily dose of 1.6g OD in the maintenance phase open-label.
|
3.2g TP05 (1600 mg) /Day Maintenance Open-Label
Responders at week 12 of the induction phase remained on a daily dose of 3.2 g OD in the maintenance phase open-label.
|
4.8g TP05 (1600 mg) /Day Maintenance Open-Label
Non-responders at week 12 of the double-blind induction phase as well as non-responders at week 8 of the induction phase who responded after a second 8 weeks of extended induction treatments, were enrolled into the maintenance phase and remained on a daily dose of 4.8g OD.
|
|---|---|---|---|---|---|---|
|
Double-Blind Induction
Adverse Event
|
20
|
18
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction
Withdrawal by Subject
|
10
|
13
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction
Physician Decision
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Double-Blind Induction
non-compliance,
|
7
|
7
|
0
|
0
|
0
|
0
|
|
Extended Induction, Open-Label
Adverse Event
|
0
|
0
|
17
|
0
|
0
|
0
|
|
Extended Induction, Open-Label
Withdrawal by Subject
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Extended Induction, Open-Label
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance, Open-Label
Adverse Event
|
0
|
0
|
0
|
3
|
9
|
14
|
|
Maintenance, Open-Label
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
6
|
2
|
|
Maintenance, Open-Label
Other
|
0
|
0
|
0
|
2
|
6
|
2
|
Baseline Characteristics
TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
Baseline characteristics by cohort
| Measure |
TP05 (Mesalazine)
n=409 Participants
3.2 gram/day (g/d) once daily (OD) for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=408 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
Total
n=817 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.97 years
STANDARD_DEVIATION 14.54 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 14.11 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 14.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
238 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
378 Participants
n=5 Participants
|
386 Participants
n=7 Participants
|
764 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed/Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
47 participants
n=5 Participants
|
49 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
France
|
23 participants
n=5 Participants
|
16 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
44 participants
n=5 Participants
|
48 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
51 participants
n=5 Participants
|
50 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
59 participants
n=5 Participants
|
71 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Mayo Score
|
7.7 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Partial Mayo Clinic Score
|
5.5 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.1 • n=7 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Per Protocol
Mayo Score of \<= 2 points with no individual sub-score \> 1
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical and Endoscopic Remission
|
87 Participants
|
95 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 16Population: Intent to Treat
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=243 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 2: Clinical Response, Open-Label Extended Induction
|
183 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 38Population: Intent to Treat
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Clinical Remission
|
70.3 percentage of participant
|
33.9 percentage of participant
|
30.7 percentage of participant
|
SECONDARY outcome
Timeframe: Week 8Population: Per Protocol
Endoscopic remission was defined as a Mayo endoscopy subscore of 0
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Endoscopic Remission
|
36 Participants
|
44 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Per Protocol
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Endoscopic Response
|
185 Participants
|
196 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Per Protocol
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical Remission
|
92 Participants
|
110 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Per Protocol
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Rectal Bleeding Sub-score of 0
|
212 Participants
|
226 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Per Protocol
Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical and Endoscopic Response
|
221 Participants
|
236 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Per Protocol
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical Remission
|
93 Participants
|
113 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Per protocol
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical Response
|
223 Participants
|
233 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Per Protocol
Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Rectal Bleeding Score of 0
|
193 Participants
|
205 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8 and week 12Population: Per Protocol
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical Remission at Both Week 8 and 12
|
66 Participants
|
80 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8 and Week 12Population: Per Protocol
A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=388 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=386 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Clinical Response at Both Week 8 and Week 12
|
216 Participants
|
230 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per Protocol
Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups. The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=371 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=375 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Change in Mayo Score From Baseline
|
3.1 units on a scale
Standard Deviation 2.7
|
3.2 units on a scale
Standard Deviation 2.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per Protocol
Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician's global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=387 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=383 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Change in Partial Mayo Score From Baseline
|
2.5 units on a scale
Standard Deviation 2.2
|
2.5 units on a scale
Standard Deviation 2.2
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per Protocol
Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=387 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=383 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Change in Stool Frequency Score
|
0.9 units on a scale
Standard Deviation 1.1
|
0.9 units on a scale
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per Protocol
Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=387 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=383 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Change in Rectal Bleeding Score From Baseline
|
0.9 units on a scale
Standard Deviation 0.8
|
1.0 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per Protocol
Between-Group Difference of Physician Global Assessment Score, Change from Baseline. The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=387 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=383 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Change in Physician Global Assessment Score From Baseline
|
0.6 units on a scale
Standard Deviation 0.8
|
0.7 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: Per Protocol
Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=371 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=375 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 1: Change in Endoscopic Score From Baseline
|
0.5 units on a scale
Standard Deviation 0.9
|
0.6 units on a scale
Standard Deviation 0.8
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Intent to Treat
Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)
Outcome measures
| Measure |
TP05 (Mesalazine)
n=243 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 2: Clinical Remission
|
53 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Intent to treat
Percentage of patients achieving the endpoint rectal bleeding sub-score of 0
Outcome measures
| Measure |
TP05 (Mesalazine)
n=243 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 2: Rectal Bleeding Sub-score of 0
|
146 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Intent to Treat
Percentage of patients achieving the endpoint stool frequency sub-score of 0
Outcome measures
| Measure |
TP05 (Mesalazine)
n=243 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 2: Stool Frequency 0
|
64 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Indent to Treat
Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=243 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 2: Urgency
|
109 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: Intent to Treat
Percentage of Patients Experiencing Complications related to UC
Outcome measures
| Measure |
TP05 (Mesalazine)
n=243 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 2: UC-Related Complications
|
0.0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Clinical Response
|
94.1 percentage of participants
|
83.9 percentage of participants
|
78.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Mayo Score of \<= 2 points with no individual sub-score \> 1
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Clinical and Endoscopic Remission
|
65.8 percentage of participants
|
39.4 percentage of participants
|
29.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and \> 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Clinical and Endoscopic Response
|
89.6 percentage of participants
|
78.1 percentage of participants
|
69.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Percentage of each dose group achieving an endoscopy sub score of 0
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Endoscopic Remission
|
37.6 percentage of participants
|
32.4 percentage of participants
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Endoscopic Response
|
73.8 percentage of participants
|
58.8 percentage of participants
|
53.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Percentage of each dose group achieving the endpoint rectal bleeding subscore 0
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Rectal Bleeding Sub Score of 0
|
88.1 percentage of participants
|
76.3 percentage of participants
|
74.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Patients achieving a Stool Frequency sub-score of 0
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: Stool Frequency Sub-score 0
|
148 Participants
|
101 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days.
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: No Urgency
|
161 Participants
|
173 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: Week 38Population: Intent to Treat
Percentage of Patients with Complications related to UC
Outcome measures
| Measure |
TP05 (Mesalazine)
n=202 Participants
3.2g/day once daily for 12 weeks (blinded),
|
Asacol (Mesalazine, Tillotts Pharma AG)
n=274 Participants
3.2g/d twice daily for 12 weeks (blinded),
|
4.8g/Day Maintenance Open-Label
n=199 Participants
Original non-responders at week 8 of the induction phase (Period 1) who responded to treatment after a second 8 weeks of extended induction open-label (Period 2), were enrolled into the maintenance phase open-label (Period 3) and remained on a daily dose of 4.8g.
|
|---|---|---|---|
|
Period 3: UC-Related Complications
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
TP05/TP05
Serious events: 24 serious events
Other events: 58 other events
Deaths: 0 deaths
Asacol/TP05
Serious events: 18 serious events
Other events: 75 other events
Deaths: 0 deaths
TP05 Extended Induction
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
TP05
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Asacol
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TP05/TP05
n=409 participants at risk
Double-blind Induction Phase: TP05, and Open-Label Maintenance Phase: TP05
|
Asacol/TP05
n=408 participants at risk
Double-blind Induction Phase: Asacol, and Open-Label Maintenance Phase: TP05
|
TP05 Extended Induction
n=243 participants at risk
Extended Induction only, Open-Label
|
TP05
n=409 participants at risk
Double-blind Induction Phase only
|
Asacol
n=408 participants at risk
Double-blind Induction Phase only
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Deterioration ulcerative colities
|
2.2%
9/409 • Number of events 10 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
1.5%
6/408 • Number of events 7 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.98%
4/409 • Number of events 5 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.98%
4/408 • Number of events 4 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Gastrointestinal disorders
Proctitis
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
2/409 • Number of events 2 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.49%
2/408 • Number of events 2 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Infections and infestations
Clostridium dificile
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.41%
1/243 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Cardiac disorders
Artrial fibrilation
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.41%
1/243 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Infections and infestations
Chronic tonsilitis
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Vascular disorders
Cryoglobulinemic vasculitis
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Infections and infestations
Flue
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Infections and infestations
Pneumonia
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Gastrointestinal disorders
Chronic pancreatitis
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Cardiac disorders
Unstable angina
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Infections and infestations
Perichondritis
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Renal and urinary disorders
Acute heamorrhagic cystitis
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deformation
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.41%
1/243 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Psychiatric disorders
Depression
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.49%
2/408 • Number of events 2 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Metabolism and nutrition disorders
Diabetes melitus
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.25%
1/408 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
|
Pregnancy, puerperium and perinatal conditions
Fading fetus
|
0.24%
1/409 • Number of events 1 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/409 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/408 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
Other adverse events
| Measure |
TP05/TP05
n=409 participants at risk
Double-blind Induction Phase: TP05, and Open-Label Maintenance Phase: TP05
|
Asacol/TP05
n=408 participants at risk
Double-blind Induction Phase: Asacol, and Open-Label Maintenance Phase: TP05
|
TP05 Extended Induction
n=243 participants at risk
Extended Induction only, Open-Label
|
TP05
n=409 participants at risk
Double-blind Induction Phase only
|
Asacol
n=408 participants at risk
Double-blind Induction Phase only
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Worsening of UC
|
14.2%
58/409 • Number of events 59 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
18.4%
75/408 • Number of events 75 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
0.00%
0/243 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
6.4%
26/409 • Number of events 27 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
5.4%
22/408 • Number of events 22 • 2 years, 11 months
Adverse Events (AEs) were analysed for each arm of the double-blind Induction Phase, for the Open-Label Extended Induction Phase and combined for the double-blind Induction Phase and the Open-Label Maintenance Phase but not for the Open-Label Maintenance Phase separately. In adding safety results of the Maintenance Phase to the safety results of the Induction Phase ensured that one occurence of an AE was counted as one AE and not as two when AEs continued from one phase to the other.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place