Trial Outcomes & Findings for A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313) (NCT NCT01709305)
NCT ID: NCT01709305
Last Updated: 2018-08-21
Results Overview
HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
5570 participants
Primary outcome timeframe
Phase 2 Baseline (Week 20) and Week 44
Results posted on
2018-08-21
Participant Flow
Adult Chinese participants (≥18 and ≤75 years of age) with a diagnosis of Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control were selected to participate in this study.
There were 2344 participants who achieved A1C\<7% in Phase 1; they completed Phase 1 and did not enter Phase 2. Of the remaining 2589 participants, 377 participants did not meet randomization criteria to enter Phase 2.
Participant milestones
| Measure |
Phase 1: Sitagliptin + Metformin
During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
|
Phase 2: Metformin + Sitagliptin + Glimepiride
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
|
Phase 2: Metformin + Sitagliptin + Repaglinide
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
|
Phase 2: Metformin + Sitagliptin + Acarbose
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
|
Phase 2: Metformin + Sitagliptin + Gliclazide
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
|
|---|---|---|---|---|---|
|
Phase 1
STARTED
|
5570
|
0
|
0
|
0
|
0
|
|
Phase 1
COMPLETED
|
4933
|
0
|
0
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
637
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
552
|
550
|
556
|
554
|
|
Phase 2
COMPLETED
|
0
|
500
|
505
|
508
|
507
|
|
Phase 2
NOT COMPLETED
|
0
|
52
|
45
|
48
|
47
|
Reasons for withdrawal
| Measure |
Phase 1: Sitagliptin + Metformin
During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
|
Phase 2: Metformin + Sitagliptin + Glimepiride
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
|
Phase 2: Metformin + Sitagliptin + Repaglinide
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
|
Phase 2: Metformin + Sitagliptin + Acarbose
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
|
Phase 2: Metformin + Sitagliptin + Gliclazide
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
|
|---|---|---|---|---|---|
|
Phase 1
Clinical Adverse Event
|
80
|
0
|
0
|
0
|
0
|
|
Phase 1
Death
|
2
|
0
|
0
|
0
|
0
|
|
Phase 1
Hyperglycemia (lack of efficacy)
|
13
|
0
|
0
|
0
|
0
|
|
Phase 1
Laboratory Adverse Event
|
16
|
0
|
0
|
0
|
0
|
|
Phase 1
Lost to Follow-up
|
147
|
0
|
0
|
0
|
0
|
|
Phase 1
Travel, moving, etc.
|
30
|
0
|
0
|
0
|
0
|
|
Phase 1
Physician Decision
|
13
|
0
|
0
|
0
|
0
|
|
Phase 1
Protocol Violation
|
118
|
0
|
0
|
0
|
0
|
|
Phase 1
Withdrawal by Subject
|
218
|
0
|
0
|
0
|
0
|
|
Phase 2
Clinical Adverse Event
|
0
|
10
|
10
|
6
|
11
|
|
Phase 2
Death
|
0
|
0
|
1
|
0
|
0
|
|
Phase 2
Hyperglycemia (lack of efficacy)
|
0
|
0
|
0
|
0
|
2
|
|
Phase 2
Laboratory Adverse Event
|
0
|
1
|
0
|
1
|
1
|
|
Phase 2
Lost to Follow-up
|
0
|
10
|
6
|
9
|
5
|
|
Phase 2
Travel, moving, etc.
|
0
|
2
|
3
|
3
|
5
|
|
Phase 2
Physician Decision
|
0
|
2
|
0
|
1
|
2
|
|
Phase 2
Protocol Violation
|
0
|
19
|
19
|
13
|
9
|
|
Phase 2
Withdrawal by Subject
|
0
|
8
|
6
|
15
|
12
|
Baseline Characteristics
A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
Baseline characteristics by cohort
| Measure |
Overall Study
n=5535 Participants
During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).
|
|---|---|
|
Age, Continuous
|
53.1 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2240 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3295 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase 2 Baseline (Week 20) and Week 44Population: Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.
HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=414 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=418 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=472 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=418 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)
|
-0.65 Percent
95% Confidence Interval 0.84 • Interval -0.73 to -0.57
|
-0.62 Percent
95% Confidence Interval 0.84 • Interval -0.69 to -0.54
|
-0.46 Percent
95% Confidence Interval 0.83 • Interval -0.53 to -0.38
|
-0.69 Percent
95% Confidence Interval 0.90 • Interval -0.77 to -0.61
|
SECONDARY outcome
Timeframe: Phase 2 Baseline (Week 20), Week 44Population: All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.
Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=501 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=502 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=509 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=506 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)
|
0.4 kg
Standard Deviation 2.6
|
0.2 kg
Standard Deviation 2.5
|
-0.9 kg
Standard Deviation 2.5
|
0.2 kg
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: From Week 20 through Week 44Population: All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.
Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Percentage of Participants With Hypoglycemia Events (Phase 2)
|
8.9 Percentage of Participants
|
6.1 Percentage of Participants
|
0.5 Percentage of Participants
|
3.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Week 20 through Week 44Population: All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.
The percentage of participants with a GI AE of "nausea" was reported.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
0.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Week 20 through Week 44Population: All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.
The percentage of participants with a GI AE of "vomiting" was reported.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Percentage of Participants With a GI AE of Vomiting (Phase 2)
|
0.2 Percentage of Participants
|
0 Percentage of Participants
|
0.2 Percentage of Participants
|
0.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Week 20 through Week 44Population: All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.
The percentage of participants with a GI AE of "diarrhea" was reported.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Percentage of Participants With a GI AE of Diarrhea (Phase 2)
|
0.5 Percentage of Participants
|
0.4 Percentage of Participants
|
0.4 Percentage of Participants
|
0.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: From Week 20 through Week 44Population: All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.
The percentage of participants with a GI AE of "abdominal pain" was reported.
Outcome measures
| Measure |
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 Participants
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 Participants
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 Participants
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 Participants
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|
|
Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
0.2 Percentage of Participants
|
Adverse Events
Phase 1: Sitagliptin + Metformin
Serious events: 63 serious events
Other events: 66 other events
Deaths: 0 deaths
Phase 2: Metformin + Sitagliptin + Acarbose
Serious events: 11 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2: Metformin + Sitagliptin + Repaglinide
Serious events: 9 serious events
Other events: 33 other events
Deaths: 0 deaths
Phase 2: Metformin + Sitagliptin + Gliclazide
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase 2: Metformin + Sitagliptin + Glimepiride
Serious events: 8 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: Sitagliptin + Metformin
n=5527 participants at risk
During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 participants at risk
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 participants at risk
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 participants at risk
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 participants at risk
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|---|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Angina Pectoris
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Angina Unstable
|
0.09%
5/5527 • Number of events 5 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Eye disorders
Cataract
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Eye disorders
Diabetic Retinopathy
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Eye disorders
Entropion
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Eye disorders
Optic Ischaemic Neuropathy
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Eye disorders
Pterygium
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
General disorders
Sudden Death
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Hepatobiliary disorders
Diabetic Hepatopathy
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Anal Abscess
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.37%
2/545 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Epididymitis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Otitis Media
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Pneumonia
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Spermatic Cord Funiculitis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Vestibular Neuronitis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Abdominal Injury
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.55%
3/545 • Number of events 3 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Metabolism and nutrition disorders
Gout
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Adenoma
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasm
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Cerebral Haematoma
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Cerebral Infarction
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.36%
2/551 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Lacunar Infarction
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Myasthenia Gravis
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Vascular Headache
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Renal and urinary disorders
Calculus Bladder
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
2/5527 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Renal and urinary disorders
Renal Colic
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Surgical and medical procedures
Incisional Drainage
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Surgical and medical procedures
Interventional Procedure
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Vascular disorders
Essential Hypertension
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Vascular disorders
Hypertension
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Vascular disorders
Varicose Ulceration
|
0.02%
1/5527 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.36%
2/550 • Number of events 2 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/545 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/545 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
General disorders
Vascular Stent Occlusion
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Liver Abscess
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/545 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Parotitis
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/545 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/551 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/545 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/545 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/550 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/549 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.00%
0/5527 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/551 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/545 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.18%
1/550 • Number of events 1 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.00%
0/549 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
Other adverse events
| Measure |
Phase 1: Sitagliptin + Metformin
n=5527 participants at risk
During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
|
Phase 2: Metformin + Sitagliptin + Acarbose
n=551 participants at risk
During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Repaglinide
n=545 participants at risk
During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Gliclazide
n=550 participants at risk
During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
Phase 2: Metformin + Sitagliptin + Glimepiride
n=549 participants at risk
During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.2%
66/5527 • Number of events 84 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
0.54%
3/551 • Number of events 5 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
6.1%
33/545 • Number of events 51 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
3.6%
20/550 • Number of events 35 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
8.7%
48/549 • Number of events 72 • Up to 46 Weeks
All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
- Publication restrictions are in place
Restriction type: OTHER