Trial Outcomes & Findings for The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study (NCT NCT02676466)
NCT ID: NCT02676466
Last Updated: 2024-05-07
Results Overview
Changes in the Interleukin-6 Level Between the Groups
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
289 participants
Primary outcome timeframe
Changes from baseline to month 12
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
Fish Oil Active
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Losartan Placebo
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active + Losartan Active
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months.
|
Fish Oil Active + Losartan Placebo
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
|
Fish Oil Placebo + Losartan Active
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
|
Fish Oil Placebo + Losartan Placebo
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
109
|
71
|
26
|
17
|
26
|
13
|
13
|
14
|
|
Overall Study
COMPLETED
|
105
|
66
|
24
|
17
|
23
|
12
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
2
|
0
|
3
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Fish Oil Active
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Losartan Placebo
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active + Losartan Active
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months.
|
Fish Oil Active + Losartan Placebo
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
|
Fish Oil Placebo + Losartan Active
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
|
Fish Oil Placebo + Losartan Placebo
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
1
|
0
|
3
|
1
|
1
|
1
|
Baseline Characteristics
The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
Baseline characteristics by cohort
| Measure |
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams /day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
109 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
13 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
289 Participants
n=114 Participants
|
|
Age, Continuous
|
78 years
STANDARD_DEVIATION 5 • n=99 Participants
|
77 years
STANDARD_DEVIATION 5 • n=107 Participants
|
78 years
STANDARD_DEVIATION 5 • n=206 Participants
|
77 years
STANDARD_DEVIATION 6 • n=7 Participants
|
77 years
STANDARD_DEVIATION 6 • n=31 Participants
|
79 years
STANDARD_DEVIATION 7 • n=30 Participants
|
76 years
STANDARD_DEVIATION 5 • n=3 Participants
|
78 years
STANDARD_DEVIATION 5 • n=6 Participants
|
78 years
STANDARD_DEVIATION 5 • n=114 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
152 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
137 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Minority (non-white only),self-report
|
24 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
64 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
109 participants
n=99 Participants
|
71 participants
n=107 Participants
|
26 participants
n=206 Participants
|
17 participants
n=7 Participants
|
26 participants
n=31 Participants
|
13 participants
n=30 Participants
|
13 participants
n=3 Participants
|
14 participants
n=6 Participants
|
289 participants
n=114 Participants
|
|
IL-6
|
3.7 pg/ml
STANDARD_DEVIATION 1.5 • n=99 Participants
|
4.4 pg/ml
STANDARD_DEVIATION 1.7 • n=107 Participants
|
3.5 pg/ml
STANDARD_DEVIATION 1.3 • n=206 Participants
|
5.7 pg/ml
STANDARD_DEVIATION 3.7 • n=7 Participants
|
2.8 pg/ml
STANDARD_DEVIATION 1.6 • n=31 Participants
|
3.1 pg/ml
STANDARD_DEVIATION 1.4 • n=30 Participants
|
4.3 pg/ml
STANDARD_DEVIATION 1.2 • n=3 Participants
|
4.2 pg/ml
STANDARD_DEVIATION 1.6 • n=6 Participants
|
3.9 pg/ml
STANDARD_DEVIATION 1.7 • n=114 Participants
|
PRIMARY outcome
Timeframe: Changes from baseline to month 12Changes in the Interleukin-6 Level Between the Groups
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Changes in the Interleukin-6 Level Between Groups
|
3.8 pg/ml
Standard Deviation 10.0
|
0 pg/ml
Standard Deviation 2.4
|
-0.1 pg/ml
Standard Deviation 2.7
|
-0.6 pg/ml
Standard Deviation 1.0
|
-0.3 pg/ml
Standard Deviation 1.0
|
-0.2 pg/ml
Standard Deviation 1.8
|
-1.4 pg/ml
Standard Deviation 0.9
|
-1.0 pg/ml
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: 12 monthsThe 400 meter walk test at usual pace is used to evaluate major mobility disability (MMD), defined as the inability to walk ¼ mile or 400 meters.
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Major Mobility Disability
|
15 Participants
|
20 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 monthsA low score on the SPPB based on 4 m walk, balance \& chair stands tests is a risk factor for disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The summary score and components of the SPPB have good reliability (ICCs range from 0.88 to 0.92). Higher scores are better. Range 0-12.
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Short Physical Performance Battery (SPPB)
|
8.4 units on a scale
Standard Deviation 2.7
|
8.6 units on a scale
Standard Deviation 2.3
|
8.1 units on a scale
Standard Deviation 2.5
|
8.2 units on a scale
Standard Deviation 2.5
|
8.6 units on a scale
Standard Deviation 2.5
|
7.3 units on a scale
Standard Deviation 2.1
|
8.5 units on a scale
Standard Deviation 2.1
|
9.1 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 12 monthsFrailty will be characterized with Fried criteria developed by Fried et al. that employ self-reported exhaustion, unintentional weight loss, low energy expenditure, slow gait speed, and weak grip strength. Those with \>3 of the 5 factors are judged to be frail, those with 1 or 2 factors as pre-frail, and those with no factors as non-frail.
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Exhibiting Frailty
|
1 Participants
|
15 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. Scoring will be taken from the best results of 3 trials. Males scores range from 88 pounds as very poor to 141 pounds as excellent with an average of 105-113 pounds. Females scores range from 44 pounds as very poor to 84 pounds as excellent with an average of 57-65 pounds.
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Isometric Hand Grip Strength
|
27.5 pounds
Standard Deviation 11.0
|
24.8 pounds
Standard Deviation 8.5
|
25.3 pounds
Standard Deviation 7.3
|
25.9 pounds
Standard Deviation 9.2
|
22.4 pounds
Standard Deviation 9.5
|
19.8 pounds
Standard Deviation 8.7
|
27.6 pounds
Standard Deviation 8.4
|
23.6 pounds
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: month 12Peak torque was measured at a rotational speed of 60 degrees per second using a commercially-available Isokinetic Dynamometer (Biodex). Torque was measured during maximal knee extension and flexion reported in Newton Meters.
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Peak Torque of the Knee Extensor and Flexor Muscles
|
78.6 Newton meters
Standard Deviation 28.6
|
81.3 Newton meters
Standard Deviation 34.0
|
77.7 Newton meters
Standard Deviation 30.8
|
87.6 Newton meters
Standard Deviation 35.5
|
85.3 Newton meters
Standard Deviation 29.8
|
76.6 Newton meters
Standard Deviation 19.2
|
84.0 Newton meters
Standard Deviation 52.8
|
86.1 Newton meters
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: month 12The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Range: 0-100. A lower score indicates more disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Losartan Placebo
n=17 Participants
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active
n=109 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 Participants
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Fish Oil Active + Losartan Active
n=26 Participants
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams/day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screenin
|
Fish Oil Active + Losartan Placebo
n=13 Participants
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams/day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
Cellulose Based (Losartan Placeb
|
Fish Oil Placebo + Losartan Active
n=13 Participants
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams/day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measure
|
Fish Oil Placebo + Losartan Placebo
n=14 Participants
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
|---|---|---|---|---|---|---|---|---|
|
Short Form Health Survey (SF-36) - Physical Component Score
|
41.3 score on a scale
Standard Deviation 9.0
|
41.9 score on a scale
Standard Deviation 7.9
|
42.6 score on a scale
Standard Deviation 9.7
|
41.8 score on a scale
Standard Deviation 9.8
|
41.9 score on a scale
Standard Deviation 8.6
|
42.7 score on a scale
Standard Deviation 8.2
|
46.6 score on a scale
Standard Deviation 7.4
|
47.9 score on a scale
Standard Deviation 6.7
|
Adverse Events
Fish Oil Active
Serious events: 30 serious events
Other events: 73 other events
Deaths: 0 deaths
Fish Oil Placebo
Serious events: 17 serious events
Other events: 46 other events
Deaths: 2 deaths
Losartan Active
Serious events: 3 serious events
Other events: 22 other events
Deaths: 1 deaths
Losartan Placebo
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Fish Oil Active + Losartan Active
Serious events: 8 serious events
Other events: 20 other events
Deaths: 0 deaths
Fish Oil Active + Losartan Placebo
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Fish Oil Placebo + Losartan Active
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Fish Oil Placebo + Losartan Placebo
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fish Oil Active
n=109 participants at risk
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 participants at risk
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 participants at risk
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Losartan Placebo
n=17 participants at risk
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active + Losartan Active
n=26 participants at risk
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months.
|
Fish Oil Active + Losartan Placebo
n=13 participants at risk
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
|
Fish Oil Placebo + Losartan Active
n=13 participants at risk
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
|
Fish Oil Placebo + Losartan Placebo
n=14 participants at risk
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
AMNESIA
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
AORTIC VALVE DISEASE
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
2.8%
3/109 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.8%
2/109 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
CARDIAC DISORDERS - OTHER, SPECIFY
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
2.8%
3/109 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Gastrointestinal disorders
COLONIC HEMORRHAGE
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL OBSTRUCTION
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Injury, poisoning and procedural complications
FALL
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
2.8%
3/109 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
HEART FAILURE
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Vascular disorders
HEMATOMA
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Vascular disorders
HYPOTENSION
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
INTRACRANIAL HEMORRHAGE
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED LUMBAR SPINE
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Infections and infestations
LUNG INFECTION
|
1.8%
2/109 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
2.8%
2/71 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
ORTHOPEDIC NEUROLOGIC
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Renal and urinary disorders
RENAL CALCULI
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Skin and subcutaneous tissue disorders
SCALP PAIN
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Infections and infestations
SKIN INFECTION
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
STROKE
|
1.8%
2/109 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES, OTHER, LEFT KNEE REPLACEMENT
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
SYNCOPE
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACKS
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
Other adverse events
| Measure |
Fish Oil Active
n=109 participants at risk
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
Omega-3 fish oil: The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
|
Fish Oil Placebo
n=71 participants at risk
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
Corn Oil (Fish oil Placebo): The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
|
Losartan Active
n=26 participants at risk
This group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Losartan: The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
|
Losartan Placebo
n=17 participants at risk
This group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
Cellulose Based (Losartan Placebo): The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
|
Fish Oil Active + Losartan Active
n=26 participants at risk
This group will receive both the Losartan and Omega-3 fish oil. Losartan will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
Omega-3 fish oil will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six months.
|
Fish Oil Active + Losartan Placebo
n=13 participants at risk
This group will receive the Omega-3 fish oil which will be administered at a dose of 1.4 grams per day for the first six months. Based on tolerability and inflammation level, dose may either continue at 1.4 grams per day or be increased to 2.8 grams per day for the remaining six month.
In addition, this group will receive a placebo which will be matching to the losartan. The placebo cellulose based capsule are obtained in 25 mg and 50 mg capsules. The shell capsules are cellulose based. Placebo and LO have identical shape, color, taste and weight. the doses will be administered at doses corresponding to the losartan.
|
Fish Oil Placebo + Losartan Active
n=13 participants at risk
This group will receive a placebo which will be matching to the Omega-3 fish oil. The placebo corn oil are obtained in gel caps and they have identical shape, color, taste and weight. The doses will be administered at doses corresponding to the Omega-3 fish oil.
In addition, this group will receive the Losartan which will be administered at a starting dose of 25 milligrams per day. Based on tolerability, losartan will continue at a dose of either 25 milligrams per day or 50 milligrams per day for the first six months. Based on continued tolerability and inflammation level, dose may either continue at 25 or 50 milligrams per day or be increased to 100 milligrams per day for the remaining six months.
|
Fish Oil Placebo + Losartan Placebo
n=14 participants at risk
This group will receive a placebo which will be matching to both the omega-3 fish oil and losartan which will be administered at doses corresponding to doses administered for omega-3 fish oil and losartan throughout the 12 month study.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
NON-SERIOUS AES - Other
|
63.3%
69/109 • Number of events 144 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
56.3%
40/71 • Number of events 80 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
76.9%
20/26 • Number of events 64 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
88.2%
15/17 • Number of events 26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
73.1%
19/26 • Number of events 32 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
76.9%
10/13 • Number of events 27 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
53.8%
7/13 • Number of events 15 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
78.6%
11/14 • Number of events 29 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Any Adverse Event
|
67.0%
73/109 • Number of events 166 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
64.8%
46/71 • Number of events 97 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
84.6%
22/26 • Number of events 74 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
94.1%
16/17 • Number of events 35 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
76.9%
20/26 • Number of events 46 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
92.3%
12/13 • Number of events 34 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
76.9%
10/13 • Number of events 21 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
78.6%
11/14 • Number of events 34 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Atrial Fibrillation
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
2.8%
2/71 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Cough
|
3.7%
4/109 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
4.2%
3/71 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
11.5%
3/26 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Dizziness/Presyncope
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
23.1%
6/26 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
19.2%
5/26 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
38.5%
5/13 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
14.3%
2/14 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Fall (mechanical)
|
9.2%
10/109 • Number of events 10 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
9.9%
7/71 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
17.6%
3/17 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
2/26 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
30.8%
4/13 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
14.3%
2/14 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Fatigue
|
1.8%
2/109 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
4.2%
3/71 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Syncope
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - GI Upset
|
6.4%
7/109 • Number of events 7 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.0%
5/71 • Number of events 5 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
11.5%
3/26 • Number of events 4 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Hyperglycemia
|
0.92%
1/109 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Hyperkalemia
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Severe Hyperglycemic Episode
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Drop in hemoglobin
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Hypotension
|
5.5%
6/109 • Number of events 6 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
2.8%
2/71 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Drop in eGFR
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
2/26 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
3.8%
1/26 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Acute Renal Failure
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Angiodema
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
|
General disorders
NON-SERIOUS AES - Stroke or TIA
|
0.00%
0/109 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/71 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/17 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/26 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/13 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
0.00%
0/14 • Adverse events were collected from each participant beginning with screening until closeout of the study. Participants were queried quarterly (every 3 months) but could report adverse events in-between visits. Participants were followed for 12 months.
To minimize reporting bias, adverse events originating from the reported event collected during assessment visits are presented. These were completed every 3 months.
|
Additional Information
ENRGISE Coordinating Center Project Manager
University of Florida
Phone: 352-294-5800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place