Trial Outcomes & Findings for One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension (NCT NCT00695955)
NCT ID: NCT00695955
Last Updated: 2011-04-19
Results Overview
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
669 participants
Primary outcome timeframe
56 weeks.
Results posted on
2011-04-19
Participant Flow
Participants enrolled at 39 investigative sites in Chile, Mexico and the United States from 22 June 2007 to 30 April 2010.
Participants with essential hypertension were enrolled in a once-daily (QD) treatment group.
Participant milestones
| Measure |
Azilsartan Medoxomil
Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Cohort 1
STARTED
|
362
|
|
Cohort 1
COMPLETED
|
260
|
|
Cohort 1
NOT COMPLETED
|
102
|
|
Cohort 2
STARTED
|
307
|
|
Cohort 2
COMPLETED
|
203
|
|
Cohort 2
NOT COMPLETED
|
104
|
Reasons for withdrawal
| Measure |
Azilsartan Medoxomil
Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Cohort 1
Adverse Event
|
26
|
|
Cohort 1
Protocol Violation
|
2
|
|
Cohort 1
Lost to Follow-up
|
30
|
|
Cohort 1
Withdrawal by Subject
|
25
|
|
Cohort 1
Lack of Efficacy
|
3
|
|
Cohort 1
Other
|
16
|
|
Cohort 2
Adverse Event
|
24
|
|
Cohort 2
Protocol Violation
|
5
|
|
Cohort 2
Lost to Follow-up
|
38
|
|
Cohort 2
Withdrawal by Subject
|
28
|
|
Cohort 2
Lack of Efficacy
|
4
|
|
Cohort 2
Other
|
5
|
Baseline Characteristics
One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Azilsartan Medoxomil
n=669 Participants
Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Age, Customized
<45 years (Cohort 1)
|
81 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years (Cohort 1)
|
233 participants
n=5 Participants
|
|
Age, Customized
≥65 years (Cohort 1)
|
48 participants
n=5 Participants
|
|
Age, Customized
<45 years (Cohort 2)
|
90 participants
n=5 Participants
|
|
Age, Customized
Between 45 and 64 years (Cohort 2)
|
193 participants
n=5 Participants
|
|
Age, Customized
≥65 years (Cohort 2)
|
24 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female (Cohort 1)
|
173 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male (Cohort 1)
|
189 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female (Cohort 2)
|
144 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male (Cohort 2)
|
163 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 weeks.Population: Full Analysis Set.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Outcome measures
| Measure |
Cohort 1
n=362 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
Number of Participants
|
267 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.
Percentage of Participants
|
73.8 participants
|
PRIMARY outcome
Timeframe: 56 weeks.Population: Full Analysis Set.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Outcome measures
| Measure |
Cohort 1
n=307 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
Number of Participants
|
241 participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.
Percentage of Participants
|
78.5 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set.
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Outcome measures
| Measure |
Cohort 1
n=362 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 4
|
-10.1 mmHg
Standard Deviation 15.21
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 8
|
-13.1 mmHg
Standard Deviation 16.72
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 12
|
-21.5 mmHg
Standard Deviation 15.80
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 16
|
-25.4 mmHg
Standard Deviation 15.09
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 26
|
-26.3 mmHg
Standard Deviation 15.97
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 36
|
-27.3 mmHg
Standard Deviation 16.63
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 46
|
-28.1 mmHg
Standard Deviation 17.21
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Week 56
|
-25.2 mmHg
Standard Deviation 18.05
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.
Final Visit
|
-22.1 mmHg
Standard Deviation 18.64
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full Analysis Set.
The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Outcome measures
| Measure |
Cohort 1
n=307 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 4
|
-14.4 mmHg
Standard Deviation 13.57
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 8
|
-17.5 mmHg
Standard Deviation 15.07
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 12
|
-23.8 mmHg
Standard Deviation 15.97
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 16
|
-26.2 mmHg
Standard Deviation 15.65
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 26
|
-24.8 mmHg
Standard Deviation 15.25
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 36
|
-22.5 mmHg
Standard Deviation 14.89
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 46
|
-23.8 mmHg
Standard Deviation 15.35
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Week 56
|
-24.2 mmHg
Standard Deviation 15.96
|
|
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2
Final Visit
|
-22.7 mmHg
Standard Deviation 17.14
|
SECONDARY outcome
Timeframe: 52 weeks.Population: Full Analysis Set.
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Outcome measures
| Measure |
Cohort 1
n=362 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 4
|
-8.9 mmHg
Standard Deviation 8.73
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 8
|
-11.0 mmHg
Standard Deviation 9.97
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 12
|
-15.9 mmHg
Standard Deviation 9.12
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 16
|
-18.7 mmHg
Standard Deviation 9.06
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 26
|
-18.6 mmHg
Standard Deviation 9.15
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 36
|
-19.9 mmHg
Standard Deviation 9.13
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 46
|
-19.8 mmHg
Standard Deviation 9.67
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Week 56
|
-18.4 mmHg
Standard Deviation 9.52
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.
Final Visit
|
-16.5 mmHg
Standard Deviation 10.23
|
SECONDARY outcome
Timeframe: 52 weeks.Population: Full Analysis Set.
The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Outcome measures
| Measure |
Cohort 1
n=307 Participants
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 4
|
-10.6 mmHg
Standard Deviation 9.23
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 8
|
-12.3 mmHg
Standard Deviation 9.05
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 12
|
-16.8 mmHg
Standard Deviation 9.48
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 16
|
-18.2 mmHg
Standard Deviation 10.28
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 26
|
-17.7 mmHg
Standard Deviation 10.95
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 36
|
-16.2 mmHg
Standard Deviation 9.08
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 46
|
-17.2 mmHg
Standard Deviation 9.57
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Week 56
|
-17.9 mmHg
Standard Deviation 10.85
|
|
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.
Final Visit
|
-16.2 mmHg
Standard Deviation 11.05
|
Adverse Events
Cohort 1
Serious events: 30 serious events
Other events: 134 other events
Deaths: 0 deaths
Cohort 2
Serious events: 22 serious events
Other events: 106 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=362 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
Cohort 2
n=307 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.55%
2/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Maculopathy
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
2/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Septic shock
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Splenic haematoma
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope vasovagal
|
0.55%
2/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.65%
2/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.28%
1/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.33%
1/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Cohort 1
n=362 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.
|
Cohort 2
n=307 participants at risk
Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
14.4%
52/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
44/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
10.5%
38/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
28/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
8.8%
32/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
16/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
25/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.5%
20/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.2%
26/362 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.6%
11/307 • Treatment-emergent adverse events (TEAEs) defined as any AEs, regardless of relationship to study drug, that occur after the first dose of study drug and within 14 days after last dose, or if an SAE, within 30 days after the last dose of study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER