Trial Outcomes & Findings for Comprehensive vs. Assisted Management of Mood and Pain Symptoms (NCT NCT01757301)
NCT ID: NCT01757301
Last Updated: 2019-03-13
Results Overview
The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
296 participants
Primary outcome timeframe
12 months
Results posted on
2019-03-13
Participant Flow
Two participants were excluded from the study after enrollment. Both participants failed screening and were considered ineligible.
Participant milestones
| Measure |
Assisted Symptom Management (ASM)
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
147
|
|
Overall Study
COMPLETED
|
134
|
133
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comprehensive vs. Assisted Management of Mood and Pain Symptoms
Baseline characteristics by cohort
| Measure |
Assisted Symptom Management (ASM)
n=147 Participants
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=147 Participants
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
56.9 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
57.4 years
STANDARD_DEVIATION 12.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
257 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
233 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
147 Participants
n=99 Participants
|
147 Participants
n=107 Participants
|
294 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.
Outcome measures
| Measure |
Assisted Symptom Management (ASM)
n=140 Participants
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=140 Participants
This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.
"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Composite Z-score of Pain-anxiety-depression Severity
|
-0.52 units on a scale
Standard Deviation 1.05
|
-0.65 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Outcome measures
| Measure |
Assisted Symptom Management (ASM)
n=140 Participants
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=140 Participants
This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.
"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)
|
6.0 units on a scale
Standard Deviation 1.9
|
6.1 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes.
Outcome measures
| Measure |
Assisted Symptom Management (ASM)
n=140 Participants
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=140 Participants
This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.
"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Patient Health Questionnaire 9-item Depression Scale (PHQ-9)
|
11.4 units on a scale
Standard Deviation 5.9
|
10.3 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes.
Outcome measures
| Measure |
Assisted Symptom Management (ASM)
n=140 Participants
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=140 Participants
This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.
"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)
|
8.4 units on a scale
Standard Deviation 6.2
|
7.5 units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.
The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.
Outcome measures
| Measure |
Assisted Symptom Management (ASM)
n=140 Participants
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules. Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=140 Participants
This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs.
"monotherapy" (ASM only). Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Brief Pain Inventory (BPI)
|
5.0 units on a scale
Standard Deviation 2.3
|
5.0 units on a scale
Standard Deviation 2.2
|
Adverse Events
Assisted Symptom Management (ASM)
Serious events: 18 serious events
Other events: 13 other events
Deaths: 1 deaths
Comprehensive Symptom Management (CSM)
Serious events: 30 serious events
Other events: 72 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Assisted Symptom Management (ASM)
n=147 participants at risk
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=147 participants at risk
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Psychiatric disorders
Endorsed Suicidal Thoughts
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Psychiatric disorders
Hospitalization for Suicidal Behavior
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
2.7%
4/147 • Number of events 4 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pneumonia
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
General disorders
Hospitalization for Influenza
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Renal and urinary disorders
Hospitalization for kidney stone
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Injury, poisoning and procedural complications
Broken kneecap
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Nervous system disorders
Hospitalization for TIA
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Infections and infestations
Hospitalization for wound
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
2.0%
3/147 • Number of events 4 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization for planned knee replacement
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization for planned angioplasty
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Cardiac disorders
Hospitalization for heart catheterization
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Endocrine disorders
Hospitalization for thyroidectomy
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization for planned hip surgery
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization for planned hernia repair
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Gastrointestinal disorders
Hospitalization following emergency appendectomy
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Gastrointestinal disorders
Hospitalization for diverticulitis
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Gastrointestinal disorders
Hospitalization for gastroparesis
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization for planned autologous fascial sling surgery
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Blood and lymphatic system disorders
Diagnosis of Hodgkins Lymphoma
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Injury, poisoning and procedural complications
Hospitalization following fall from ladder
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Cardiac disorders
ER visit for atypical chest pain
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization for planned septoplasty
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
General disorders
Hospitalization for substance abuse
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
2.0%
3/147 • Number of events 3 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Renal and urinary disorders
Hospitalization following renal failure
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Vascular disorders
Diagnosis of deep vein thrombosis
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Injury, poisoning and procedural complications
ER visit for fall
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
1.4%
2/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Renal and urinary disorders
Yearly surveillance for known prostate cancer
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
ER visit for trouble breathing
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Injury, poisoning and procedural complications
Surgery following dog attack injuries
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Cardiac disorders
Hospitalization for heart stent placement
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalization following elective laminectomy/fusion
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Blood and lymphatic system disorders
Hospitalization for polycythemia likely secondary to renal mass
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pneumonitis
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Blood and lymphatic system disorders
Hospitalization for infection
|
0.68%
1/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Surgical and medical procedures
Hospitalized following stem cell transplant
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for COPD
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 2 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for bronchitis
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pulmonary edema
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
General disorders
Hospitalization for atypical chest pain
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for collapsed lung
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
Infections and infestations
Hospitalization following amputation of left leg
|
0.68%
1/147 • Number of events 1 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
Other adverse events
| Measure |
Assisted Symptom Management (ASM)
n=147 participants at risk
There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
Assisted Symptom Management (ASM): There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
|
Comprehensive Symptom Management (CSM)
n=147 participants at risk
This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
Comprehensive Symptom Management (CSM): This arm couples ASM with care management by a nurse-physician team, thus testing "combined" therapy vs. "monotherapy" (ASM only).
|
|---|---|---|
|
Psychiatric disorders
Triggered Suicidal Ideation Screener
|
8.8%
13/147 • Number of events 17 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
10.9%
16/147 • Number of events 23 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
|
General disorders
Known medication side effects
|
0.00%
0/147 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
41.5%
61/147 • Number of events 92 • SAEs and AEs were assessed for each participant from baseline date through the date the 12 month interview was completed or through the date the participant withdrew participation (if applicable). The average timeframe among all participants was 365 days.
SAEs were solicited and documented from all participants during 6 and 12 month outcome interviews and if spontaneously reported by participants. SAE/AEs were additionally solicited and documented from CSM participants during automated symptom monitoring, multiple nurse care manager phone calls and were documented when the nurse found evidence of an SAE/AE in a CSM participant's medical record. This method led to a much greater identification rate of AEs in CSM than in ASM participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place