Trial Outcomes & Findings for Comparative Effectiveness Research in Veterans With PTSD (NCT NCT01928732)
NCT ID: NCT01928732
Last Updated: 2022-02-02
Results Overview
The primary outcome is the change of CAPS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE and CPT. Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
916 participants
Primary outcome timeframe
immediate post-treatment, 3 and 6 months
Results posted on
2022-02-02
Participant Flow
Participant milestones
| Measure |
Behavioral: Prolonged Exposure (PE)
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Overall Study
STARTED
|
455
|
461
|
|
Overall Study
COMPLETED
|
326
|
334
|
|
Overall Study
NOT COMPLETED
|
129
|
127
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
Baseline characteristics by cohort
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
Total
n=916 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
n=455 Participants
|
44.9 years
n=461 Participants
|
45.2 years
n=916 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=455 Participants
|
92 Participants
n=461 Participants
|
186 Participants
n=916 Participants
|
|
Sex: Female, Male
Male
|
361 Participants
n=455 Participants
|
369 Participants
n=461 Participants
|
730 Participants
n=916 Participants
|
|
Race/Ethnicity, Customized
White
|
301 Participants
n=455 Participants
|
289 Participants
n=461 Participants
|
590 Participants
n=916 Participants
|
|
Race/Ethnicity, Customized
Black
|
119 Participants
n=455 Participants
|
130 Participants
n=461 Participants
|
249 Participants
n=916 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
18 Participants
n=455 Participants
|
15 Participants
n=461 Participants
|
33 Participants
n=916 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=455 Participants
|
11 Participants
n=461 Participants
|
25 Participants
n=916 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
7 Participants
n=455 Participants
|
10 Participants
n=461 Participants
|
17 Participants
n=916 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=455 Participants
|
25 Participants
n=461 Participants
|
46 Participants
n=916 Participants
|
|
Service Era
Vietnam
|
82 Participants
n=455 Participants
|
77 Participants
n=461 Participants
|
159 Participants
n=916 Participants
|
|
Service Era
Gulf War
|
85 Participants
n=455 Participants
|
87 Participants
n=461 Participants
|
172 Participants
n=916 Participants
|
|
Service Era
OEF/OIF/OND
|
260 Participants
n=455 Participants
|
270 Participants
n=461 Participants
|
530 Participants
n=916 Participants
|
|
Service Era
Other
|
66 Participants
n=455 Participants
|
59 Participants
n=461 Participants
|
125 Participants
n=916 Participants
|
|
Post-high school education
|
216 Participants
n=455 Participants
|
192 Participants
n=461 Participants
|
408 Participants
n=916 Participants
|
|
Unemployed
|
271 Participants
n=455 Participants
|
263 Participants
n=461 Participants
|
534 Participants
n=916 Participants
|
|
Married/cohabitating
|
246 Participants
n=455 Participants
|
237 Participants
n=461 Participants
|
483 Participants
n=916 Participants
|
|
Ethnicity: Spanish, Hispanic or Latino
|
67 Participants
n=455 Participants
|
72 Participants
n=461 Participants
|
139 Participants
n=916 Participants
|
|
Positive VA Military Sexual Trauma Screen
|
134 Participants
n=455 Participants
|
133 Participants
n=461 Participants
|
267 Participants
n=916 Participants
|
|
Positive VA Traumatic Brain Injury Screen
|
294 Participants
n=455 Participants
|
281 Participants
n=461 Participants
|
575 Participants
n=916 Participants
|
|
Lifetime trauma exposure: Number of event types (of 17)
|
7.7 number of event types
n=455 Participants
|
7.4 number of event types
n=461 Participants
|
7.54 number of event types
n=916 Participants
|
|
Lifetime trauma exposure
Combat exposure
|
357 Participants
n=455 Participants
|
347 Participants
n=461 Participants
|
704 Participants
n=916 Participants
|
|
Lifetime trauma exposure
Any sexual trauma
|
166 Participants
n=455 Participants
|
163 Participants
n=461 Participants
|
329 Participants
n=916 Participants
|
|
Lifetime trauma exposure
Physical assault
|
386 Participants
n=455 Participants
|
408 Participants
n=461 Participants
|
794 Participants
n=916 Participants
|
|
Lifetime trauma exposure
Disaster exposure
|
391 Participants
n=455 Participants
|
385 Participants
n=461 Participants
|
776 Participants
n=916 Participants
|
|
Lifetime trauma exposure
Serious accident
|
385 Participants
n=455 Participants
|
389 Participants
n=461 Participants
|
774 Participants
n=916 Participants
|
|
Lifetime trauma exposure
Life-threatening illness or injury
|
154 Participants
n=455 Participants
|
163 Participants
n=461 Participants
|
317 Participants
n=916 Participants
|
|
Lifetime trauma exposure
Other traumatic event
|
371 Participants
n=455 Participants
|
354 Participants
n=461 Participants
|
725 Participants
n=916 Participants
|
|
PTSD disability
Approved
|
186 Participants
n=453 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
202 Participants
n=459 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
388 Participants
n=912 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
|
PTSD disability
Pending
|
116 Participants
n=453 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
129 Participants
n=459 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
245 Participants
n=912 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
|
PTSD disability
Denied
|
26 Participants
n=453 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
19 Participants
n=459 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
45 Participants
n=912 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
|
PTSD disability
Never applied
|
125 Participants
n=453 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
109 Participants
n=459 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
234 Participants
n=912 Participants • Two participants in the PE group and two participants in the CPT group did not report their "PTSD Disability" status.
|
|
Receiving psychotherapy
|
95 Participants
n=455 Participants
|
98 Participants
n=461 Participants
|
193 Participants
n=916 Participants
|
|
Taking psychotropic medication
|
303 Participants
n=455 Participants
|
317 Participants
n=461 Participants
|
620 Participants
n=916 Participants
|
|
Any current comorbid psychiatric disorder
|
343 Participants
n=455 Participants
|
371 Participants
n=461 Participants
|
714 Participants
n=916 Participants
|
|
Any current comorbid psychiatric disorder
Mood disorder
|
309 Participants
n=455 Participants
|
332 Participants
n=461 Participants
|
641 Participants
n=916 Participants
|
|
Any current comorbid psychiatric disorder
Anxiety disorder
|
139 Participants
n=455 Participants
|
166 Participants
n=461 Participants
|
305 Participants
n=916 Participants
|
|
Any current comorbid psychiatric disorder
Substance use disorders
|
32 Participants
n=455 Participants
|
40 Participants
n=461 Participants
|
72 Participants
n=916 Participants
|
|
Any current comorbid psychiatric disorder
Obsessive compulsive disorder
|
19 Participants
n=455 Participants
|
29 Participants
n=461 Participants
|
48 Participants
n=916 Participants
|
|
Any lifetime comorbid psychiatric disorder
|
417 Participants
n=455 Participants
|
424 Participants
n=461 Participants
|
841 Participants
n=916 Participants
|
|
Any lifetime comorbid psychiatric disorder
Mood disorder
|
398 Participants
n=455 Participants
|
400 Participants
n=461 Participants
|
798 Participants
n=916 Participants
|
|
Any lifetime comorbid psychiatric disorder
Anxiety disorder
|
149 Participants
n=455 Participants
|
181 Participants
n=461 Participants
|
330 Participants
n=916 Participants
|
|
Any lifetime comorbid psychiatric disorder
Substance use disorders
|
130 Participants
n=455 Participants
|
112 Participants
n=461 Participants
|
242 Participants
n=916 Participants
|
|
Any lifetime comorbid psychiatric disorder
Obsessive compulsive disorder
|
24 Participants
n=455 Participants
|
36 Participants
n=461 Participants
|
60 Participants
n=916 Participants
|
|
Clinician Administered PTSD Scale-5
|
39.9 score on a scale
n=455 Participants
|
40.3 score on a scale
n=461 Participants
|
40.1 score on a scale
n=916 Participants
|
|
Posttraumatic Diagnostic Scale
|
50.7 score on a scale
n=455 Participants
|
50.5 score on a scale
n=461 Participants
|
50.63 score on a scale
n=916 Participants
|
|
Beck Depression Inventory-II
|
30.3 score on a scale
n=455 Participants
|
30.0 score on a scale
n=461 Participants
|
30.2 score on a scale
n=916 Participants
|
|
Beck Depression Inventory-II Suicidality (BDI-II Item 9)
|
163 Participants
n=455 Participants
|
156 Participants
n=461 Participants
|
319 Participants
n=916 Participants
|
|
Spielberger Trait Anger Expression Inventory
State Anger
|
17.8 score on a scale
n=455 Participants
|
17.9 score on a scale
n=461 Participants
|
17.9 score on a scale
n=916 Participants
|
|
Spielberger Trait Anger Expression Inventory
Trait Anger
|
24.1 score on a scale
n=455 Participants
|
24.2 score on a scale
n=461 Participants
|
24.2 score on a scale
n=916 Participants
|
|
Spielberger Trait Anger Expression Inventory
Anger Expression
|
37.3 score on a scale
n=455 Participants
|
36.4 score on a scale
n=461 Participants
|
36.9 score on a scale
n=916 Participants
|
|
Brief Addiction Monitor
|
0.8 score on a scale
n=455 Participants
|
0.8 score on a scale
n=461 Participants
|
0.8 score on a scale
n=916 Participants
|
|
Short Inventory of Problems-Revised
|
3.5 score on a scale
n=455 Participants
|
3.3 score on a scale
n=461 Participants
|
3.4 score on a scale
n=916 Participants
|
|
World Health Organization Disability Adjustment Scale-II
|
29.4 score on a scale
n=455 Participants
|
29.7 score on a scale
n=461 Participants
|
29.6 score on a scale
n=916 Participants
|
|
World Health Organization Quality of Life-BREF
Physical Health
|
44.4 score on a scale
n=455 Participants
|
43.7 score on a scale
n=461 Participants
|
44.1 score on a scale
n=916 Participants
|
|
World Health Organization Quality of Life-BREF
Psychological
|
46.5 score on a scale
n=455 Participants
|
46.4 score on a scale
n=461 Participants
|
46.5 score on a scale
n=916 Participants
|
|
World Health Organization Quality of Life-BREF
Social Relationships
|
41.3 score on a scale
n=455 Participants
|
40.6 score on a scale
n=461 Participants
|
41.0 score on a scale
n=916 Participants
|
|
World Health Organization Quality of Life-BREF
Environment
|
58.2 score on a scale
n=455 Participants
|
57.4 score on a scale
n=461 Participants
|
57.8 score on a scale
n=916 Participants
|
|
Number of patients preferring PE treatment at baseline
|
232 Participants
n=455 Participants
|
214 Participants
n=461 Participants
|
446 Participants
n=916 Participants
|
PRIMARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe primary outcome is the change of CAPS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). We chose to use the average in the six months post-treatment in the definition of primary outcome (versus using a single post-treatment timepoint) because we anticipate that improvement established during the course of treatment will be sustained in the 6 months after treatment for both PE and CPT. Possible range for CAPS-5 total score 0-80. Higher score indicates more severe PTSD.
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)
6 Months
|
24.8 score on a scale
Interval 23.2 to 26.2
|
26.9 score on a scale
Interval 25.4 to 28.4
|
|
Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)
Posttreatment
|
24.3 score on a scale
Interval 22.8 to 25.2
|
27.2 score on a scale
Interval 25.5 to 28.9
|
|
Change in PTSD Symptom Severity on the Clinician-Administered PTSD Scale (CAPS)
3 Months
|
26.4 score on a scale
Interval 25.1 to 27.8
|
28.7 score on a scale
Interval 27.2 to 30.2
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe PDS-5 is a 24-item self-report measure that assesses PTSD symptom severity in the last month according to DSM-5 criteria. The outcome is the change of PDS-5 total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for PDS-5 score 0-80. Higher PDS-5 Score indicates more severe PTSD Symptoms.
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Posttraumatic Diagnostic Scale (PDS-5)
Posttreatment
|
33.5 score on a scale
Interval 31.3 to 35.6
|
36.7 score on a scale
Interval 34.7 to 38.7
|
|
Posttraumatic Diagnostic Scale (PDS-5)
3 Months
|
34.5 score on a scale
Interval 32.5 to 36.4
|
37.5 score on a scale
Interval 35.6 to 39.4
|
|
Posttraumatic Diagnostic Scale (PDS-5)
6 Months
|
33.6 score on a scale
Interval 31.6 to 35.5
|
36.7 score on a scale
Interval 34.8 to 38.7
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsBDI-II is a brief, self-report inventory designed to measure the severity of depression symptomatology. The outcome is the change of BDI-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for BDI-II 0-63. Higher score indicates more severe depressive symptoms (0-13 minimal, 14-29 mild, 20-28 moderate, 29-63 severe).
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Beck Depression Inventory-II (BDI-II)
Posttreatment
|
22.0 score on a scale
Interval 20.5 to 23.5
|
22.7 score on a scale
Interval 21.3 to 24.1
|
|
Beck Depression Inventory-II (BDI-II)
3 Months
|
22.2 score on a scale
Interval 20.9 to 23.5
|
23.6 score on a scale
Interval 22.3 to 24.9
|
|
Beck Depression Inventory-II (BDI-II)
6 Months
|
21.9 score on a scale
Interval 20.6 to 23.3
|
22.9 score on a scale
Interval 21.5 to 24.2
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe STAXI is a commonly used measure of trait and state anxiety. The outcome is the change of STAI total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for STAXI 44-176. Higher score indicates greater intensity of anger.
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Spielberger State Anger Inventory (STAXI)
6 Months
|
93.2 score on a scale
Interval 91.1 to 95.4
|
94.5 score on a scale
Interval 92.6 to 96.4
|
|
Spielberger State Anger Inventory (STAXI)
Posttreatment
|
93.4 score on a scale
Interval 91.4 to 95.4
|
94.6 score on a scale
Interval 92.7 to 96.5
|
|
Spielberger State Anger Inventory (STAXI)
3 Months
|
93.2 score on a scale
Interval 91.2 to 95.3
|
94.7 score on a scale
Interval 92.8 to 96.6
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe SIP-R assesses alcohol-related consequences. The outcome is the change of SIP-R total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for SIP-R 0-51. Higher score indicates more severe adverse consequences of substance use.
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Short Inventory of Problems - Revised (SIP-R)
Posttreatment
|
2.61 score on a scale
Interval 1.89 to 3.34
|
2.49 score on a scale
Interval 1.76 to 3.23
|
|
Short Inventory of Problems - Revised (SIP-R)
3 Months
|
2.42 score on a scale
Interval 1.58 to 3.25
|
2.29 score on a scale
Interval 1.6 to 2.97
|
|
Short Inventory of Problems - Revised (SIP-R)
6 Months
|
3.09 score on a scale
Interval 2.22 to 3.95
|
1.72 score on a scale
Interval 0.93 to 2.51
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe BAM measures an individual's health, alcohol, and drug use. The outcome is the change of BAM total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Range: 0-4 points. Higher score indicates worse outcome (i.e., more severe addiction).
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Brief Addiction Monitor (BAM)
Posttreatment
|
0.88 score on a scale
Interval 0.73 to 1.03
|
0.86 score on a scale
Interval 0.69 to 1.02
|
|
Brief Addiction Monitor (BAM)
3 Months
|
1.0 score on a scale
Interval 0.84 to 1.16
|
0.94 score on a scale
Interval 0.78 to 1.1
|
|
Brief Addiction Monitor (BAM)
6 Months
|
0.96 score on a scale
Interval 0.82 to 1.11
|
0.80 score on a scale
Interval 0.64 to 0.97
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe WHO-DAS-II is an assessment instrument for health and disability. The outcome is the change of WHO-DAS-II total score from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHODAS-II 12-60. Higher score indicates more difficulty and disability due to health condition.
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
World Health Organization Disability Assessment Schedule (WHO-DAS-II)
Posttreatment
|
28.6 score on a scale
Interval 27.7 to 29.4
|
28.6 score on a scale
Interval 27.8 to 29.4
|
|
World Health Organization Disability Assessment Schedule (WHO-DAS-II)
6 Months
|
28.5 score on a scale
Interval 27.5 to 29.4
|
28.5 score on a scale
Interval 27.4 to 29.5
|
|
World Health Organization Disability Assessment Schedule (WHO-DAS-II)
3 Months
|
28.0 score on a scale
Interval 27.1 to 29.0
|
28.7 score on a scale
Interval 27.7 to 29.7
|
SECONDARY outcome
Timeframe: immediate post-treatment, 3 and 6 monthsThe WHOQoL-BREF is a quality of life assessment. The outcome is the change of WHOQoL-BREF assessment sub-category (Physical Health, Psychological, Social Relationships, Environment) scores from baseline (pre-treatment) to the average in the six months post-treatment (measured at immediate post-treatment, 3 and 6 months follow-up visits). Possible range for WHOQOL-BREF 0-100, Physical Health 0-100, Psychological 0-100, Social Relationships 0-100, and Environment 0-100. Higher score indicates better satisfaction with life.
Outcome measures
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 Participants
PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 Participants
CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Physical Health - Posttreatment
|
47.0 score on a scale
Interval 44.5 to 49.5
|
48.6 score on a scale
Interval 46.0 to 51.1
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Environment - 6 Months
|
62.3 score on a scale
Interval 60.5 to 64.1
|
60.9 score on a scale
Interval 59.2 to 62.6
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Physical Health - 3 Months
|
47.0 score on a scale
Interval 45.7 to 48.2
|
47.0 score on a scale
Interval 45.8 to 48.2
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Physical Health - 6 Months
|
47.1 score on a scale
Interval 45.8 to 48.4
|
46.9 score on a scale
Interval 45.6 to 48.2
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Psychological - Posttreatment
|
49.0 score on a scale
Interval 47.5 to 50.5
|
48.9 score on a scale
Interval 47.3 to 50.5
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Psychological - 3 Months
|
49.1 score on a scale
Interval 47.7 to 50.5
|
48.1 score on a scale
Interval 46.7 to 49.4
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Psychological - 6 Months
|
49.5 score on a scale
Interval 47.9 to 51.1
|
49.1 score on a scale
Interval 47.6 to 50.7
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Social Relationship - Posttreatment
|
45.4 score on a scale
Interval 43.1 to 47.8
|
43.9 score on a scale
Interval 41.6 to 46.3
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Social Relationship - 3 Months
|
46.2 score on a scale
Interval 43.6 to 48.8
|
44.1 score on a scale
Interval 41.6 to 46.6
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Social Relationship - 6 Months
|
46.2 score on a scale
Interval 43.8 to 48.6
|
45.5 score on a scale
Interval 42.8 to 48.2
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Environment - Posttreatment
|
61.1 score on a scale
Interval 59.3 to 62.9
|
59.5 score on a scale
Interval 57.6 to 61.3
|
|
World Health Organization Quality of Life (WHOQoL-BREF)
Environment - 3 Months
|
61.5 score on a scale
Interval 59.8 to 63.2
|
59.8 score on a scale
Interval 58.2 to 61.4
|
Adverse Events
Behavioral: Prolonged Exposure (PE)
Serious events: 55 serious events
Other events: 42 other events
Deaths: 1 deaths
Behavioral: Cognitive Processing Therapy (CPT)
Serious events: 63 serious events
Other events: 65 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 participants at risk
Prolonged Exposure (PE) is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 participants at risk
Cognitive Processing Therapy (CPT) consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.44%
2/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Accidental Poisoning
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Adverse Drug Reaction
|
0.44%
2/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Alcohol Abuse
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Alcohol Detoxification
|
0.44%
2/455 • Number of events 5 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.65%
3/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Aortic aneurysm
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.44%
2/455 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Investigations
Blood Glucose Decreased
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Investigations
Blood Glucose Increased
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Reproductive system and breast disorders
Breast Enlargement
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Calcinosis
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Chest Pain
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 5 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Death
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Depression
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Depressive Symptom
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Diverticulitis
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Drug Administration Error
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Drug Detoxification
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Drug Interaction
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Drug Use Disorder
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Encephalopathy
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Eye Operation Complication
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 6 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Hernia
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Hernia Repair
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 5 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Immune system disorders
Hypersensitivity
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Vascular disorders
Hypertension
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Vascular disorders
Hypertensive Crisis
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Infected Bite
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Kidney Infection
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.22%
1/455 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Knee Operation
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Localized Infection
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Lung Infection
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Melaena
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.87%
4/461 • Number of events 6 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Neck Surgery
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 8 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.44%
2/455 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Reproductive system and breast disorders
Organic erectile dysfunction
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 5 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Panic Attack
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.65%
3/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Panic Disorder
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Pharyngeal operation
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Physical Assault
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 7 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Pneumonia
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Post-Procedural Complication
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Post Procedural Infection
|
0.22%
1/455 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Prostatic operation
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.44%
2/455 • Number of events 5 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.65%
3/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Scar excision
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Snake Bite
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Spinal Fusion Surgery
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Suicidal ideation
|
1.3%
6/455 • Number of events 10 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
2.6%
12/461 • Number of events 18 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Renal and urinary disorders
Urinary Retention
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Urinary Tract Infection
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.22%
1/455 • Number of events 9 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Violence-related symptom
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
Other adverse events
| Measure |
Behavioral: Prolonged Exposure (PE)
n=455 participants at risk
Prolonged Exposure (PE) is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure.
|
Behavioral: Cognitive Processing Therapy (CPT)
n=461 participants at risk
Cognitive Processing Therapy (CPT) consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Adverse Drug Reaction
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Aggression
|
0.44%
2/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Agitation
|
0.44%
2/455 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Alcohol Abuse
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Angina Pectoris
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.87%
4/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Burglary Victim
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Chest Pain
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Crying
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Death of Companion
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Death of Relative
|
0.44%
2/455 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Drug Administration Error
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Investigations
Drug screen positive
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Drug Use Disorder
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Electric Shock
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Emotional Distress
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Exaggerated startle response
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Eye disorders
Eye Swelling
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Facial Paralysis
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Flashback
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Homeless
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Homicidal Ideation
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Hypervigilance
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Impaired Driving Ability
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Imprisonment
|
0.44%
2/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.87%
4/461 • Number of events 5 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Intentional Self-Injury
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Intrusive Thoughts
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Irritability
|
0.44%
2/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Legal Problem
|
0.66%
3/455 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Loss of Employment
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Infections and infestations
Lung Infection
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Marital Problem
|
0.22%
1/455 • Number of events 2 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.65%
3/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
General disorders
Pain
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Cardiac disorders
Palpitations
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Panic Attack
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Paraesthesia
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Physical Assault
|
0.44%
2/455 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
1.3%
6/461 • Number of events 9 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Post-traumatic Stress Disorder
|
1.1%
5/455 • Number of events 8 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.87%
4/461 • Number of events 4 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Nervous system disorders
Seizure
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Shoplifting
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Sick Relative
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Stress
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.43%
2/461 • Number of events 3 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Substance Use
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.3%
6/455 • Number of events 8 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
2.6%
12/461 • Number of events 18 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Social circumstances
Suicide of Relative
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Surgery
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Surgical and medical procedures
Therapy Cessation
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.22%
1/455 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.00%
0/461 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
|
Psychiatric disorders
Violence-related symptom
|
0.00%
0/455 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
0.22%
1/461 • Number of events 1 • Up to approximately 12 months
Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The presentation or publication of any data collected by investigators on participants entered into the VA cooperative study is under the control of the study's Executive Committee. No individual participating investigator is permitted to perform analyses or interpretations or to make public presentations or seek publication of any of the data other than under the auspices and approval of the Executive Committee.
- Publication restrictions are in place
Restriction type: OTHER