Trial Outcomes & Findings for Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain (NCT NCT01054820)
NCT ID: NCT01054820
Last Updated: 2012-08-16
Results Overview
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
COMPLETED
PHASE4
123 participants
Baseline, End of Treatment (last visit up to Day 15)
2012-08-16
Participant Flow
Participant milestones
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Overall Study
STARTED
|
123
|
|
Overall Study
COMPLETED
|
121
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Baseline characteristics by cohort
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Age Continuous
|
38.8 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: Intent to Treat (ITT) population: had at least one application of FLECTOR® Patch, pain survey data at Baseline, and at least 1 follow-up visit. EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 5: Please rate your pain by marking the box beside the number that best describes your pain on the average (over the last 24 hours); rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours
Baseline
|
6.46 scores on a scale
Standard Deviation 1.30
|
|
Mean Change From Baseline to End of Treatment (EOT) in Response to Modified Brief Pain Inventory (mBPI) Question 5: Average Pain Over the Last 24 Hours
Change from baseline to EOT
|
-3.95 scores on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: ITT population; EOT score was the last non-missing score obtained on a treatment day, including the final treatment visit.
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 1: Have you had pain other than everyday kinds of pain?; response = Yes or No.
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain
Change at EOT: Bsl=Yes, EOT=Yes
|
93 participants
|
|
Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain
Change at EOT: Bsl=Yes, EOT=No
|
21 participants
|
|
Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain
Change at EOT: Bsl=No, EOT=Yes
|
0 participants
|
|
Number of Participants With Change From Baseline (Bsl) to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 1: Pain Other Than Everyday Kind of Pain
Change at EOT: Bsl=No, EOT=No
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 3: Rate your pain at its worst in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours
Baseline
|
7.59 scores on a scale
Standard Deviation 1.19
|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 3: Pain at Its Worst in the Last 24 Hours
Change from baseline to EOT
|
-4.50 scores on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 4: Rate your pain at its least in the last 24 hours; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours
Baseline
|
5.46 scores on a scale
Standard Deviation 1.84
|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 4: Pain at Its Least in the Last 24 Hours
Change from baseline to EOT
|
-3.50 scores on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day.
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 6: Rate your pain right now; rated on an 11 point Likert rating scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now
Baseline
|
6.49 scores on a scale
Standard Deviation 1.76
|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 6: Pain Right Now
Change from baseline to EOT
|
-4.28 scores on a scale
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: ITT population; EOT score calculated by taking average of any non-missing scores recorded last 3 days of treatment; if no score on those days, EOT was single, most recent non-missing score recorded on a treatment day. N=number of participants with analyzable data for Question 8 at observation.
Participant-rated instrument to assess functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Question 8: Rate your percent reduction in pain from Baseline (0% = no relief to 100% = complete relief).
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=119 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline
Baseline
|
2.94 percent
Standard Deviation 11.23
|
|
Mean Change From Baseline to EOT in Response to Modified Brief Pain Inventory (mBPI) Question 8: Percent Reduction in Pain From Baseline
Change from baseline to EOT
|
67.30 percent
Standard Deviation 30.58
|
SECONDARY outcome
Timeframe: End of Treatment (up to Day 15)Population: ITT population
Global pain relief as assessed by participant using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
5=Complete Relief
|
53 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
4=A Lot Of Improvement
|
42 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
3=Moderate Improvement
|
12 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
2=Slight Improvement
|
12 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Participant
1=No Change
|
4 participants
|
SECONDARY outcome
Timeframe: End of Treatment (up to Day 15)Population: ITT population
Participants' global pain relief as assessed by investigator using a 5-point scale where 5 = complete relief, 4=a lot of improvement, 3=moderate improvement, 2=slight improvement, and 1=no change.
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
4=A Lot Of Improvement
|
42 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
5=Complete Relief
|
58 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
3=Moderate Improvement
|
8 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
2=Slight Improvement
|
10 participants
|
|
Number of Participants Per Global Pain Relief Scores at the End of Treatment as Assessed by the Investigator
1=No Change
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (last visit up to Day 15)Population: ITT population; End-of-Treatment score was the most recent non-missing value.
The Beck Depression Inventory® II consisted of 21 items, each with 4 categorical responses ranging from 0 (I do not feel sad) to 3 (I am so sad or unhappy that I can't stand it) with maximum possible score of 63; increase in the number reflected an increase in severity. Total Beck Depression Inventory® II scores classified as follows: 1 to 10=normal ups and downs; 11 to 16=mild mood disturbance; 17 to 20=borderline clinical depression; 21 to 30=moderate depression; 31 to 40=severe depression; and \>40=extreme depression.
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Mean Change From Baseline to EOT in Beck Depression Inventory® Il
Baseline
|
3.44 scores on a scale
Standard Deviation 5.47
|
|
Mean Change From Baseline to EOT in Beck Depression Inventory® Il
Change from baseline to EOT
|
-1.54 scores on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: End of Treatment (last visit up to Day 15)Population: ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.
Participant satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
5=Very Satisfied
|
63 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
4=Satisfied
|
45 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
3=No Preference
|
6 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
2=Dissatisfied
|
8 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by Participant
1=Very Dissatisfied
|
1 participants
|
SECONDARY outcome
Timeframe: End of Treatment (last visit up to Day 15)Population: ITT; End-of-Treatment score for patch satisfaction consisted of the last value recorded.
Investigator's assessment of participants' satisfaction with the FLECTOR® Patch rated on a 5-point scale scored as 5=Very Satisfied, 4=Satisfied, 3=No Preference, 2=Dissatisfied, and 1=Very Dissatisfied.
Outcome measures
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 Participants
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
5=Very Satisfied
|
66 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
4=Satisfied
|
39 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
3=No Preference
|
9 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
2=Dissatisfied
|
8 participants
|
|
Number of Participants Per Patch Satisfaction Response at the End of Treatment as Assessed by the Investigator
1=Very Dissatisfied
|
1 participants
|
Adverse Events
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
Serious adverse events
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 participants at risk
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
General disorders
Non-cardiac chest pain
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.
n=123 participants at risk
One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
1.6%
2/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Application site rash
|
2.4%
3/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Application site pruritus
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.81%
1/123 • Baseline up to 14 days after last dose. Adverse events ongoing at the last visit were to be followed until resolution or until no further follow-up warranted.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER