Trial Outcomes & Findings for A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia (NCT NCT00830128)
NCT ID: NCT00830128
Last Updated: 2021-01-25
Results Overview
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
COMPLETED
PHASE3
106 participants
Up to 53 weeks
2021-01-25
Participant Flow
Participants received the study drug in the precedent study A0081208 (NCT00830167).
Participant milestones
| Measure |
Pregabalin
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
87
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Family obligation
|
1
|
|
Overall Study
Relocation
|
1
|
|
Overall Study
Work obligation
|
1
|
|
Overall Study
Operating a vehicle
|
1
|
Baseline Characteristics
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
Between 18 and 44 years
|
47 Participants
n=99 Participants
|
|
Age, Customized
Between 45 and 64 years
|
49 Participants
n=99 Participants
|
|
Age, Customized
>= 65 years
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 53 weeksPopulation: All participants who received at least 1 dose of the study medication.
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
All-causality adverse events (AEs)
|
102 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
All-causality SAEs
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment.
The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
|
-13.1 mm
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint
|
-9.6 Units on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint
|
1.9 Units on a scale
Standard Deviation 22.3
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint
|
-3.0 Units on a scale
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint
|
4.2 Units on a scale
Standard Deviation 21.3
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint
|
0.3 hours
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint
|
7.2 Units on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint
|
-3.7 Units on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is \< 7 hours per night.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint
Yes
|
26 Paticipants
|
|
Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint
No
|
80 Paticipants
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint
|
-4.9 Units on a scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52 or Study DiscontinuationPopulation: All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Pregabalin
n=106 Participants
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Physical Functioning
|
-0.2 Units on a scale
Standard Deviation 2.0
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Feel Good
|
-0.4 Units on a scale
Standard Deviation 2.7
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Work Missed
|
-0.5 Units on a scale
Standard Deviation 2.8
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Difficulty Working
|
-0.7 Units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Pain
|
-1.0 Units on a scale
Standard Deviation 2.3
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Fatigue
|
-0.3 Units on a scale
Standard Deviation 1.9
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Morning Tiredness
|
-0.6 Units on a scale
Standard Deviation 2.2
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Stiffness
|
-0.7 Units on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Anoxiouness
|
-0.3 Units on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint
Depression
|
-0.2 Units on a scale
Standard Deviation 2.6
|
Adverse Events
Pregabalin
Serious adverse events
| Measure |
Pregabalin
n=106 participants at risk
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Infections and infestations
Tuberculosis
|
0.94%
1/106
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
Crush Injury
|
0.94%
1/106
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
Compartment Syndrome
|
0.94%
1/106
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
Neuropathy Peripheral
|
0.94%
1/106
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
Nasal Septum Deviation
|
0.94%
1/106
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 |
Pregabalin
n=106 participants at risk
Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.5%
8/106
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
Constipation
|
21.7%
23/106
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
|
6.6%
7/106
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.
|
|
General disorders
Oedema peripheral
|
8.5%
9/106
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
Nasopharyngitis
|
31.1%
33/106
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
Fall
|
5.7%
6/106
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.
|
|
Investigations
Weight increased
|
19.8%
21/106
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
Back pain
|
5.7%
6/106
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
Fibromyalgia
|
8.5%
9/106
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
Osteoarthritis
|
7.5%
8/106
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
Dizziness
|
26.4%
28/106
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
|
11.3%
12/106
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
Somnolence
|
29.2%
31/106
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