Trial Outcomes & Findings for Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD (NCT NCT00532493)
NCT ID: NCT00532493
Last Updated: 2018-05-01
Results Overview
Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.
Results posted on
2018-05-01
Participant Flow
Participant milestones
| Measure |
Prazosin Group
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
152
|
|
Overall Study
COMPLETED
|
122
|
123
|
|
Overall Study
NOT COMPLETED
|
30
|
29
|
Reasons for withdrawal
| Measure |
Prazosin Group
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
|
Overall Study
Withdrawal by Subject
|
7
|
9
|
|
Overall Study
Physician Decision
|
1
|
6
|
|
Overall Study
Adverse Event
|
6
|
5
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
|
Overall Study
Subject Moved Away
|
3
|
1
|
|
Overall Study
Contraindicative Medication
|
1
|
0
|
Baseline Characteristics
Cooperative Studies Program #563 - Prazosin and Combat Trauma PTSD
Baseline characteristics by cohort
| Measure |
Prazosin Group
n=152 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=152 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
91 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Highest Educational Level
Grade School or Less
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Highest Educational Level
Some High School
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Highest Educational Level
High School/GED
|
35 participants
n=5 Participants
|
29 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Highest Educational Level
Some College/Ass.Degree/Tech.School
|
79 participants
n=5 Participants
|
77 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Highest Educational Level
College Graduate
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Highest Educational Level
Post Graduate/Professional Degree
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Highest Educational Level
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Highest Educational Level
Did Not Answer
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Marital Status
Single
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Marital Status
Married
|
82 participants
n=5 Participants
|
89 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Marital Status
Living Together in a Relationship
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Marital Status
Separated
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Marital Status
Divorced
|
39 participants
n=5 Participants
|
27 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Marital Status
Widowed
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Marital Status
Did Not Answer
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Major Depression
Yes
|
51 participants
n=5 Participants
|
64 participants
n=7 Participants
|
115 participants
n=5 Participants
|
|
Major Depression
No
|
101 participants
n=5 Participants
|
88 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Maintained on any Antidepressant
Yes
|
119 participants
n=5 Participants
|
117 participants
n=7 Participants
|
236 participants
n=5 Participants
|
|
Maintained on any Antidepressant
No
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI)
Yes
|
113 participants
n=5 Participants
|
113 participants
n=7 Participants
|
226 participants
n=5 Participants
|
|
Maintained on Selective Serotonin Re-uptake Inhibitors (SSRI)
No
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.Population: 17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10
Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.
Outcome measures
| Measure |
Prazosin Group
n=135 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=136 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
CAPS Recurrent Distressing Dreams Item
|
-1.9 scores on a scale
Standard Deviation 2.1
|
-1.7 scores on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.Population: 17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10
Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.
Outcome measures
| Measure |
Prazosin Group
n=135 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=136 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
-2.3 scores on a scale
Standard Deviation 4.2
|
-2.1 scores on a scale
Standard Deviation 4
|
PRIMARY outcome
Timeframe: This primary outcome measure was administered at baseline and week 10. The change of the 10-week from baseline was reported.Population: 17 participants in the prazosin group have missing data on this item at week 10; 16 participants in the placebo group have missing data on this item at week 10
Change from baseline in possible range for Clinical Global Impression of Change 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.
Outcome measures
| Measure |
Prazosin Group
n=135 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=136 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC)
|
3.3 scores on a scale
Standard Deviation 1.4
|
3.3 scores on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for PSQI global score 0-21. Higher PSQI score indicates worse quality of sleep.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Pittsburgh Sleep Quality Index
Change at Week 14
|
-3.1 scores on a scale
Standard Deviation 3.9
|
-2.7 scores on a scale
Standard Deviation 3.9
|
|
Pittsburgh Sleep Quality Index
Change at Week 18
|
-2.4 scores on a scale
Standard Deviation 4.1
|
-2.8 scores on a scale
Standard Deviation 4
|
|
Pittsburgh Sleep Quality Index
Baseline
|
14.4 scores on a scale
Standard Deviation 3.3
|
14.7 scores on a scale
Standard Deviation 3.5
|
|
Pittsburgh Sleep Quality Index
Change at Week 6
|
-2.1 scores on a scale
Standard Deviation 3.9
|
-2.4 scores on a scale
Standard Deviation 4.2
|
|
Pittsburgh Sleep Quality Index
Change at Week 10
|
-2.3 scores on a scale
Standard Deviation 4.2
|
-2.1 scores on a scale
Standard Deviation 4
|
|
Pittsburgh Sleep Quality Index
Change at Week 22
|
-2.9 scores on a scale
Standard Deviation 4
|
-2.7 scores on a scale
Standard Deviation 4.2
|
|
Pittsburgh Sleep Quality Index
Change at Week 26
|
-2.9 scores on a scale
Standard Deviation 4.3
|
-2.7 scores on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination) to assess temporal course of changes in symptoms in response to prazosin or placebo.Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in frequency and/or severity of combat trauma-related nightmares will be assessed by the CAPS Recurrent Distressing Dreams item. Possible range for Recurrent Distressing Dreams is 0-8. Higher score indicates more severe PTSD symptoms.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
CAPS Recurrent Distressing Dreams Item
Change at Week 10
|
-1.9 scores on a scale
Standard Deviation 2.1
|
-1.7 scores on a scale
Standard Deviation 2.3
|
|
CAPS Recurrent Distressing Dreams Item
Change at Week 14
|
-2.2 scores on a scale
Standard Deviation 2.2
|
-2.5 scores on a scale
Standard Deviation 2.5
|
|
CAPS Recurrent Distressing Dreams Item
Change at Week 18
|
-1.8 scores on a scale
Standard Deviation 2.3
|
-2.4 scores on a scale
Standard Deviation 2.5
|
|
CAPS Recurrent Distressing Dreams Item
Change at Week 22
|
-2.4 scores on a scale
Standard Deviation 2.3
|
-2.5 scores on a scale
Standard Deviation 2.4
|
|
CAPS Recurrent Distressing Dreams Item
Change at Week 26
|
-2.3 scores on a scale
Standard Deviation 2.5
|
-2.2 scores on a scale
Standard Deviation 2.5
|
|
CAPS Recurrent Distressing Dreams Item
Baseline
|
6.3 scores on a scale
Standard Deviation 0.9
|
6.3 scores on a scale
Standard Deviation 0.9
|
|
CAPS Recurrent Distressing Dreams Item
Change at Week 6
|
-1.3 scores on a scale
Standard Deviation 1.8
|
-1.4 scores on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for Clinical Global Impression of Change (CGIC) 1-7. As compared to baseline global condition, 1 is marked improvement, 2 is moderate improvement, 3 is minimal improvement, 4 is no change, 5 is minimal worsening, 6 is moderate worsening, and 7 is marked worsening.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Clinical Global Impression of Change
Week 6
|
3.2 scores on a scale
Standard Deviation 1.2
|
3.3 scores on a scale
Standard Deviation 1.3
|
|
Clinical Global Impression of Change
Week 10
|
3.3 scores on a scale
Standard Deviation 1.4
|
3.3 scores on a scale
Standard Deviation 1.4
|
|
Clinical Global Impression of Change
Week 14
|
3 scores on a scale
Standard Deviation 1.4
|
3 scores on a scale
Standard Deviation 1.4
|
|
Clinical Global Impression of Change
Week 18
|
3.2 scores on a scale
Standard Deviation 1.3
|
3 scores on a scale
Standard Deviation 1.4
|
|
Clinical Global Impression of Change
Week 22
|
2.9 scores on a scale
Standard Deviation 1.4
|
2.9 scores on a scale
Standard Deviation 1.3
|
|
Clinical Global Impression of Change
Week 26
|
2.9 scores on a scale
Standard Deviation 1.6
|
2.9 scores on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: The total CAPS was administered at baseline, 6, 10, 18, and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for CAPS total score is 0-136. Higher score indicates more severe PTSD symptoms.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Total CAPS Score
Baseline
|
80.7 scores on a scale
Standard Deviation 15.5
|
81.9 scores on a scale
Standard Deviation 17.1
|
|
Total CAPS Score
Change at Week 6
|
-9.9 scores on a scale
Standard Deviation 16
|
-9.1 scores on a scale
Standard Deviation 16.9
|
|
Total CAPS Score
Change at Week 10
|
-11.4 scores on a scale
Standard Deviation 17.2
|
-12.1 scores on a scale
Standard Deviation 19.4
|
|
Total CAPS Score
Change at Week 18
|
-11.6 scores on a scale
Standard Deviation 18.3
|
-17.2 scores on a scale
Standard Deviation 21.7
|
|
Total CAPS Score
Change at Week 26
|
-14.1 scores on a scale
Standard Deviation 21.8
|
-16.2 scores on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: This secondary outcome was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks to assess change in PTSD symptom severity.Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for PCL-M score 17-85. Higher PCL score indicates greater propensity for chronic and delayed PTSD.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
PTSD Checklist-Military Version (PCL-M) Score
Baseline
|
62.5 scores on a scale
Standard Deviation 11.1
|
64.3 scores on a scale
Standard Deviation 12.2
|
|
PTSD Checklist-Military Version (PCL-M) Score
Change at Week 6
|
-6.3 scores on a scale
Standard Deviation 10.6
|
-6.2 scores on a scale
Standard Deviation 11
|
|
PTSD Checklist-Military Version (PCL-M) Score
Change at Week 10
|
-7 scores on a scale
Standard Deviation 12.7
|
-5.8 scores on a scale
Standard Deviation 11.6
|
|
PTSD Checklist-Military Version (PCL-M) Score
Change at Week 14
|
-8.1 scores on a scale
Standard Deviation 12.5
|
-7.6 scores on a scale
Standard Deviation 11.6
|
|
PTSD Checklist-Military Version (PCL-M) Score
Change at Week 18
|
-7.2 scores on a scale
Standard Deviation 12.3
|
-8.4 scores on a scale
Standard Deviation 13.3
|
|
PTSD Checklist-Military Version (PCL-M) Score
Change at Week 22
|
-7.1 scores on a scale
Standard Deviation 12.9
|
-9.2 scores on a scale
Standard Deviation 13.5
|
|
PTSD Checklist-Military Version (PCL-M) Score
Change at Week 26
|
-8.2 scores on a scale
Standard Deviation 13.8
|
-9.7 scores on a scale
Standard Deviation 14
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for PHQ9 score is 0-27. Higher PHQ9 score indicates more severe depression.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ9)
Baseline
|
13.7 scores on a scale
Standard Deviation 5.9
|
14.6 scores on a scale
Standard Deviation 5.9
|
|
Patient Health Questionnaire-9 (PHQ9)
Change at Week 6
|
-1.6 scores on a scale
Standard Deviation 4.7
|
-2.8 scores on a scale
Standard Deviation 5.1
|
|
Patient Health Questionnaire-9 (PHQ9)
Change at Week 10
|
-1.9 scores on a scale
Standard Deviation 5.1
|
-2.2 scores on a scale
Standard Deviation 5.1
|
|
Patient Health Questionnaire-9 (PHQ9)
Change at Week 14
|
-1.9 scores on a scale
Standard Deviation 5.2
|
-2.6 scores on a scale
Standard Deviation 5.3
|
|
Patient Health Questionnaire-9 (PHQ9)
Change at Week 18
|
-1.6 scores on a scale
Standard Deviation 5.3
|
-2.4 scores on a scale
Standard Deviation 5.5
|
|
Patient Health Questionnaire-9 (PHQ9)
Change at Week 22
|
-2.2 scores on a scale
Standard Deviation 5.6
|
-2.5 scores on a scale
Standard Deviation 5.9
|
|
Patient Health Questionnaire-9 (PHQ9)
Change at Week 26
|
-2 scores on a scale
Standard Deviation 5.5
|
-2.8 scores on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for SF-12 PCS is 6-72. Higher SF-12 score indicates better level of health.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Baseline
|
35.4 scores on a scale
Standard Deviation 14.5
|
34.2 scores on a scale
Standard Deviation 12.2
|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Change at Week 6
|
1.8 scores on a scale
Standard Deviation 9.7
|
0.8 scores on a scale
Standard Deviation 10.2
|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Change at Week 10
|
0.3 scores on a scale
Standard Deviation 10
|
0.3 scores on a scale
Standard Deviation 10.4
|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Change at Week 14
|
1.4 scores on a scale
Standard Deviation 10.1
|
0.3 scores on a scale
Standard Deviation 10.9
|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Change at Week 18
|
0.5 scores on a scale
Standard Deviation 10
|
-0.4 scores on a scale
Standard Deviation 11.4
|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Change at Week 22
|
1.1 scores on a scale
Standard Deviation 10.9
|
-0.8 scores on a scale
Standard Deviation 13.2
|
|
SF-12 Physical Standardized Score (SF-12 PCS)
Change at Week 26
|
0.7 scores on a scale
Standard Deviation 11.8
|
-0.2 scores on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for SF-12 MCS is 5-76. Higher SF-12 score indicates better level of health.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Baseline
|
38.2 scores on a scale
Standard Deviation 9.1
|
39.4 scores on a scale
Standard Deviation 8.4
|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Change at Week 6
|
-2 scores on a scale
Standard Deviation 9.2
|
-1.3 scores on a scale
Standard Deviation 8.5
|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Change at Week 10
|
-1 scores on a scale
Standard Deviation 9.2
|
-1.1 scores on a scale
Standard Deviation 8.7
|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Change at Week 14
|
-1.5 scores on a scale
Standard Deviation 7.9
|
-1 scores on a scale
Standard Deviation 9.7
|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Change at Week 18
|
-0.2 scores on a scale
Standard Deviation 8.4
|
-0.7 scores on a scale
Standard Deviation 8.8
|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Change at Week 22
|
-0.8 scores on a scale
Standard Deviation 8.9
|
-0.6 scores on a scale
Standard Deviation 9.4
|
|
SF-12 Mental Standardized Score (SF-12 MCS)
Change at Week 26
|
-0.7 scores on a scale
Standard Deviation 8.7
|
-0.8 scores on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for QOLI is -6 to 6. Higher QOLI indicates better satisfaction with life.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Quality of Life Inventory (QOLI)
Baseline
|
0.1 scores on a scale
Standard Deviation 1.9
|
0 scores on a scale
Standard Deviation 1.9
|
|
Quality of Life Inventory (QOLI)
Change at Week 6
|
0.1 scores on a scale
Standard Deviation 1.5
|
0 scores on a scale
Standard Deviation 1.4
|
|
Quality of Life Inventory (QOLI)
Change at Week 10
|
0 scores on a scale
Standard Deviation 1.3
|
0.1 scores on a scale
Standard Deviation 1.7
|
|
Quality of Life Inventory (QOLI)
Change at Week 14
|
0.1 scores on a scale
Standard Deviation 1.5
|
0 scores on a scale
Standard Deviation 1.5
|
|
Quality of Life Inventory (QOLI)
Change at Week 18
|
0.3 scores on a scale
Standard Deviation 1.3
|
0.1 scores on a scale
Standard Deviation 1.6
|
|
Quality of Life Inventory (QOLI)
Change at Week 22
|
0.1 scores on a scale
Standard Deviation 1.4
|
0.1 scores on a scale
Standard Deviation 1.9
|
|
Quality of Life Inventory (QOLI)
Change at Week 26
|
0.2 scores on a scale
Standard Deviation 1.4
|
0.2 scores on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: This secondary outcome measure was administered at baseline, 6, 10, 14, 18, 22 and 26 weeks (or early termination).Population: 11 participants in the prazosin group have missing data on this item at one or more of the follow-up weeks; 9 participants in the placebo group have missing data at one or more of the follow-up weeks
Change from baseline in possible range for Audit-C score is 0-12. Higher score indicates heavier use of alcohol. A score of \>=4 for male and a score of \>=3 for female meets the criteria for alcohol use disorders.
Outcome measures
| Measure |
Prazosin Group
n=141 Participants
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=143 Participants
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Baseline
|
2 scores on a scale
Standard Deviation 2.8
|
2.2 scores on a scale
Standard Deviation 2.6
|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Change at Week 14
|
-0.2 scores on a scale
Standard Deviation 1.6
|
-0.4 scores on a scale
Standard Deviation 2.2
|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Change at Week 18
|
-0.2 scores on a scale
Standard Deviation 1.5
|
-0.1 scores on a scale
Standard Deviation 1.9
|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Change at Week 22
|
-0.2 scores on a scale
Standard Deviation 1.6
|
-0.3 scores on a scale
Standard Deviation 2.1
|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Change at Week 26
|
-0.3 scores on a scale
Standard Deviation 1.4
|
-0.3 scores on a scale
Standard Deviation 1.9
|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Change at Week 6
|
-0.3 scores on a scale
Standard Deviation 1.7
|
-0.3 scores on a scale
Standard Deviation 1.7
|
|
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Change at Week 10
|
-0.4 scores on a scale
Standard Deviation 1.4
|
-0.2 scores on a scale
Standard Deviation 1.7
|
Adverse Events
Prazosin Group
Serious events: 18 serious events
Other events: 142 other events
Deaths: 0 deaths
Placebo Group
Serious events: 17 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prazosin Group
n=152 participants at risk
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=152 participants at risk
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Arteriovenous malformation
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Chest pain
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
General disorders
Drug withdrawal syndrome
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Campylobacter infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Cellulitis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Sudden onset of sleep
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Alcoholic psychosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Depression
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Substance abuse
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/152
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Violence-related symptom
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
Other adverse events
| Measure |
Prazosin Group
n=152 participants at risk
Subjects randomized to this arm will be on prazosin.
prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized "first dose" effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually.
|
Placebo Group
n=152 participants at risk
Subjects randomized to this arm will be on placebo.
placebo: "sugar" pill
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Atrial fibrillation
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/152
|
0.66%
1/152 • Number of events 3
|
|
Cardiac disorders
Myocardial infarction
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Cardiac disorders
Palpitations
|
21.1%
32/152 • Number of events 37
|
15.8%
24/152 • Number of events 27
|
|
Cardiac disorders
Tachycardia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.66%
1/152 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Ear and labyrinth disorders
Motion sickness
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
3/152 • Number of events 3
|
1.3%
2/152 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Eye disorders
Abnormal sensation in eye
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
0.66%
1/152 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Presbyopia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Retinal detachment
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Eye disorders
Visual acuity reduced
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
4/152 • Number of events 6
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/152 • Number of events 3
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/152 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.3%
2/152 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
9/152 • Number of events 9
|
5.9%
9/152 • Number of events 9
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
6/152 • Number of events 6
|
7.2%
11/152 • Number of events 11
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
4/152 • Number of events 4
|
3.9%
6/152 • Number of events 7
|
|
Gastrointestinal disorders
Flatulence
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Food poisoning
|
1.3%
2/152 • Number of events 2
|
0.66%
1/152 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/152
|
2.0%
3/152 • Number of events 3
|
|
Gastrointestinal disorders
Glossodynia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
30.9%
47/152 • Number of events 61
|
27.0%
41/152 • Number of events 56
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Toothache
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
5/152 • Number of events 7
|
4.6%
7/152 • Number of events 7
|
|
General disorders
Adverse drug reaction
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Asthenia
|
36.2%
55/152 • Number of events 93
|
42.1%
64/152 • Number of events 92
|
|
General disorders
Atrophy
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Chest pain
|
2.6%
4/152 • Number of events 4
|
3.9%
6/152 • Number of events 6
|
|
General disorders
Chills
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Drug ineffective
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Drug withdrawal syndrome
|
0.66%
1/152 • Number of events 4
|
0.00%
0/152
|
|
General disorders
Feeling abnormal
|
0.00%
0/152
|
1.3%
2/152 • Number of events 2
|
|
General disorders
Feeling jittery
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Irritability
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
General disorders
Medical device complication
|
0.66%
1/152 • Number of events 2
|
0.00%
0/152
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
General disorders
Oedema
|
9.2%
14/152 • Number of events 17
|
7.2%
11/152 • Number of events 14
|
|
General disorders
Oedema peripheral
|
3.9%
6/152 • Number of events 6
|
3.3%
5/152 • Number of events 6
|
|
General disorders
Pain
|
2.0%
3/152 • Number of events 3
|
1.3%
2/152 • Number of events 2
|
|
General disorders
Pyrexia
|
1.3%
2/152 • Number of events 2
|
2.0%
3/152 • Number of events 3
|
|
General disorders
Swelling
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
General disorders
Thirst
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
General disorders
Unevaluable event
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Immune system disorders
Food allergy
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Acarodermatitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Bronchitis
|
1.3%
2/152 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Campylobacter infection
|
0.66%
1/152 • Number of events 5
|
0.00%
0/152
|
|
Infections and infestations
Cellulitis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Ear infection
|
2.0%
3/152 • Number of events 3
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Enteritis infectious
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Fungal infection
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Furuncle
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Gastroenteritis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.3%
2/152 • Number of events 2
|
2.0%
3/152 • Number of events 3
|
|
Infections and infestations
Lyme disease
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
5/152 • Number of events 6
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Parotitis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.3%
2/152 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
0.66%
1/152 • Number of events 2
|
0.00%
0/152
|
|
Infections and infestations
Sinusitis
|
1.3%
2/152 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Tooth abscess
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Tooth infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
4/152 • Number of events 4
|
0.66%
1/152 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Infections and infestations
Viral infection
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.66%
1/152 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bite
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
4/152 • Number of events 4
|
2.0%
3/152 • Number of events 3
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/152
|
0.66%
1/152 • Number of events 2
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.3%
2/152 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Colonoscopy
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Electrocardiogram abnormal
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Investigations
Endoscopy
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Glycosylated haemoglobin increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Helicobacter test positive
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Sputum culture positive
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Investigations
Weight increased
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Investigations
White blood cell count increased
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
4/152 • Number of events 4
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Gout
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/152 • Number of events 2
|
2.0%
3/152 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
5/152 • Number of events 6
|
3.3%
5/152 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
2/152 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
3/152 • Number of events 6
|
1.3%
2/152 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.0%
3/152 • Number of events 3
|
2.6%
4/152 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Amnesia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Dizziness
|
48.0%
73/152 • Number of events 107
|
41.4%
63/152 • Number of events 106
|
|
Nervous system disorders
Dizziness postural
|
34.2%
52/152 • Number of events 61
|
26.3%
40/152 • Number of events 47
|
|
Nervous system disorders
Drooling
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Head discomfort
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Headache
|
35.5%
54/152 • Number of events 71
|
42.8%
65/152 • Number of events 78
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Nervous system disorders
Lethargy
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
1.3%
2/152 • Number of events 3
|
0.00%
0/152
|
|
Nervous system disorders
Periodic limb movement disorder
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Restless legs syndrome
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Sedation
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
33.6%
51/152 • Number of events 64
|
31.6%
48/152 • Number of events 61
|
|
Nervous system disorders
Sudden onset of sleep
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Syncope
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Nervous system disorders
Tremor
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Aggression
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Alcoholic psychosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Anger
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
2.0%
3/152 • Number of events 3
|
2.0%
3/152 • Number of events 3
|
|
Psychiatric disorders
Bruxism
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Dependence
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
17.1%
26/152 • Number of events 34
|
25.0%
38/152 • Number of events 44
|
|
Psychiatric disorders
Depression
|
9.2%
14/152 • Number of events 17
|
6.6%
10/152 • Number of events 11
|
|
Psychiatric disorders
Flashback
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
21.7%
33/152 • Number of events 37
|
23.7%
36/152 • Number of events 40
|
|
Psychiatric disorders
Libido decreased
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Psychiatric disorders
Nightmare
|
1.3%
2/152 • Number of events 2
|
1.3%
2/152 • Number of events 2
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Stress
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Substance abuse
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
7.9%
12/152 • Number of events 14
|
15.1%
23/152 • Number of events 27
|
|
Psychiatric disorders
Violence-related symptom
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Renal and urinary disorders
Incontinence
|
7.9%
12/152 • Number of events 13
|
3.9%
6/152 • Number of events 6
|
|
Renal and urinary disorders
Micturition urgency
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.3%
2/152 • Number of events 2
|
0.66%
1/152 • Number of events 1
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/152
|
1.3%
2/152 • Number of events 2
|
|
Renal and urinary disorders
Pollakiuria
|
21.7%
33/152 • Number of events 39
|
19.7%
30/152 • Number of events 34
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Renal and urinary disorders
Urinary incontinence
|
1.3%
2/152 • Number of events 2
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Epididymitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Reproductive system and breast disorders
Priapism
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.6%
7/152 • Number of events 7
|
3.9%
6/152 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.6%
7/152 • Number of events 7
|
1.3%
2/152 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.66%
1/152 • Number of events 1
|
2.0%
3/152 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
37.5%
57/152 • Number of events 71
|
32.2%
49/152 • Number of events 54
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
5/152 • Number of events 5
|
1.3%
2/152 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.66%
1/152 • Number of events 2
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/152
|
1.3%
2/152 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
2.0%
3/152 • Number of events 3
|
0.00%
0/152
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.66%
1/152 • Number of events 1
|
1.3%
2/152 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/152
|
0.66%
1/152 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.66%
1/152 • Number of events 1
|
2.6%
4/152 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
2/152 • Number of events 2
|
2.6%
4/152 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Social circumstances
Substance use
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Chondroplasty
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Nerve block
|
0.66%
1/152 • Number of events 1
|
0.00%
0/152
|
|
Surgical and medical procedures
Polypectomy
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Surgical and medical procedures
Surgery
|
0.66%
1/152 • Number of events 1
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.6%
7/152 • Number of events 7
|
1.3%
2/152 • Number of events 3
|
|
Vascular disorders
Orthostatic hypotension
|
6.6%
10/152 • Number of events 14
|
2.6%
4/152 • Number of events 7
|
|
Vascular disorders
Hot flush
|
0.00%
0/152
|
0.66%
1/152 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER