Trial Outcomes & Findings for Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial (NCT NCT00407797)
NCT ID: NCT00407797
Last Updated: 2021-01-25
Results Overview
28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
136 participants
Primary outcome timeframe
Week 9 to Week 21 or End of Treatment (early termination)
Results posted on
2021-01-25
Participant Flow
A total of 152 subjects were screened and 136 subjects were assigned to study treatment.
Participant milestones
| Measure |
Pregabalin
150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
|
|---|---|
|
Overall Study
STARTED
|
136
|
|
Overall Study
Full Analysis Set
|
135
|
|
Overall Study
COMPLETED
|
118
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Pregabalin
150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Other
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial
Baseline characteristics by cohort
| Measure |
Pregabalin
n=136 Participants
150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
|
|---|---|
|
Age, Customized
18 - 44 years
|
107 participants
n=5 Participants
|
|
Age, Customized
45 - 64 years
|
25 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
28-Day Seizure Rate
|
7.8 seizure rate
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
28 day seizure frequency in Subjects with <= 6 and > 6 seizures during Baseline Period
<=6 seizures
|
2 seizures
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
28 day seizure frequency in Subjects with <= 6 and > 6 seizures during Baseline Period
> 6 seizures
|
12 seizures
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Sleep Disturbance
|
32.9 scores on scale
STANDARD_DEVIATION 20.9 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Snoring
|
40.1 scores on scale
STANDARD_DEVIATION 33.4 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Awaken Short of Breath
|
26.0 scores on scale
STANDARD_DEVIATION 24.8 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Quantity of Sleep
|
7.9 scores on scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Optimal Sleep
|
0.5 scores on scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Sleep Adequacy
|
64.6 scores on scale
STANDARD_DEVIATION 26.1 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
Somnolence
|
39.2 scores on scale
STANDARD_DEVIATION 24.5 • n=5 Participants
|
|
Medical Outcomes Study Sleep Scale
9-Item Sleep Problems Index
|
33.4 scores on scale
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Hospital Anxiety and Depression Scale (HADS)
Anxiety Total Score
|
8.8 score on scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Hospital Anxiety and Depression Scale (HADS)
Depression Total Score
|
7.3 score on scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 9 to Week 21 or End of Treatment (early termination)Population: Full Analysis Set (FAS): all subjects who received at least 1 dose of assigned treatment, had valid baseline seizure data, and had at least 1 subsequent rating of seizure frequency (modified intent to treat population). N=number of subjects with evaluable data.
28-day seizure rate (at observation period \[obs\]) = \[(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 \[Week 9\] date)\] \* 28. Percent change = \[(28-day seizure rate obs minus 28-day seizure rate at baseline \[b\]) divided by 28-day seizure rate b\] \* 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency.
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent Change From Baseline in 28 Day Partial Seizure Rate During Treatment Observation Phase
|
-51.2 percent change
Standard Deviation 45.2
|
SECONDARY outcome
Timeframe: Week 9 to Week 21 or End of Treatment (early termination)Population: FAS. N=number of subjects with evaluable data.
Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = \[(28-day seizure rate in observation period \[obs\] minus 28-day seizure rate at baseline \[b\] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)\] \* 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures.
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Response Ratio (RR)
|
-45.1 ratio
Standard Deviation 37.9
|
SECONDARY outcome
Timeframe: Week 21 or End of Treatment (early termination)Population: FAS.
Percent change from Baseline = \[(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline \[b\]) divided by (28-day seizure rate b) \* 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency.
Outcome measures
| Measure |
Pregabalin
n=135 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent Change From Baseline in 28-Day Partial Seizure Frequency at Week 21
|
-36.0 percent change
Standard Deviation 55.8
|
SECONDARY outcome
Timeframe: Week 9 to Week 21 or End of Treatment (early termination)Population: FAS. N=number of subjects with evaluable data.
Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency.
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period
<= 6 seizures at Baseline (n=50)
|
-57.9 percent change
Standard Deviation 44.9
|
|
Percent Change From Baseline in Seizure Frequency in Participants Who Had <=6 Seizures and >6 Seizures During the Baseline Period
> 6 seizures at Baseline (n=71)
|
-46.5 percent change
Standard Deviation 45.1
|
SECONDARY outcome
Timeframe: Week 9 to Week 21 or Early Termination (end of treatment)Population: FAS. N=number of subjects with evaluable data.
Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline).
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent of Seizure- Free Participants During the Treatment Observation Period
|
20.7 percent of participants
|
SECONDARY outcome
Timeframe: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)Population: FAS. N=number of subjects with evaluable data.
Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline).
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent of Seizure Free Participants During the Last 4 Weeks of the Treatment Observation Period
|
40.5 percent of participants
|
SECONDARY outcome
Timeframe: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)Population: FAS. N=number of subjects with evaluable data.
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent of Participants With >=50% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
|
63.6 percent of participants
|
SECONDARY outcome
Timeframe: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)Population: FAS. N=number of subjects with evaluable data.
Outcome measures
| Measure |
Pregabalin
n=121 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Percent of Participants With >=75% Reduction in Seizure Frequency (28-day Seizure Rate) Between Baseline and Final 4 Weeks of the Treatment Observation Period
|
48.8 percent of participants
|
SECONDARY outcome
Timeframe: Week 21, LOCFPopulation: FAS. LOCF = Last Observation Carried Forward.
Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC.
Outcome measures
| Measure |
Pregabalin
n=135 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: No Change
|
4.4 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Very Much Improved
|
22.4 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Much Improved
|
52.6 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Minimally Improved
|
13.8 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: No Change
|
4.3 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Minimally Worse
|
1.7 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Much Worse
|
1.7 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Very Much Worse
|
0.9 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
Week 21: Not Done
|
2.6 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Very Much Improved
|
20.7 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Much Improved
|
51.1 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Minimally Improved
|
12.6 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Minimally Worse
|
1.5 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Much Worse
|
1.5 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Very Much Worse
|
0.7 percent of participants
|
|
Treatment Satisfaction: Patient General Impression to Change (PGIC)
LOCF: Not Done
|
7.4 percent of participants
|
SECONDARY outcome
Timeframe: Week 21, LOCFPopulation: FAS. LOCF = Last Observation Carried Forward.
Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b.
Outcome measures
| Measure |
Pregabalin
n=135 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: Sleep Disturbance
|
-3.8 scores on scale
Standard Deviation 20.9
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: Sleep Disturbance
|
-4.0 scores on scale
Standard Deviation 21.1
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: Snoring
|
1.4 scores on scale
Standard Deviation 35.4
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: Snoring
|
2.2 scores on scale
Standard Deviation 34.3
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: Awaken Short of Breath
|
0.7 scores on scale
Standard Deviation 32.4
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: Awaken Short of Breath
|
0.3 scores on scale
Standard Deviation 30.9
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: Adequacy
|
4.2 scores on scale
Standard Deviation 28.0
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: Adequacy
|
4.0 scores on scale
Standard Deviation 26.9
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: Somnolence
|
0.4 scores on scale
Standard Deviation 28.3
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: Somnolence
|
-0.8 scores on scale
Standard Deviation 28.2
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: 9-Item Overall Sleep Problem Index
|
-2.2 scores on scale
Standard Deviation 16.6
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: 9-Item Overall Sleep Problem Index
|
-2.5 scores on scale
Standard Deviation 16.1
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
Week 21: Sleep Quantity
|
0.4 scores on scale
Standard Deviation 2.1
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS)
LOCF: Sleep Quantity
|
0.4 scores on scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 21, LOCFPopulation: FAS. LOCF=Last Observation Carried Forward.
Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline \[b\]) divided by MOS score b.
Outcome measures
| Measure |
Pregabalin
n=135 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale
Week 21
|
0.1 scores on scale
Standard Deviation 0.6
|
|
Change From Baseline in Sleep Interference: Medical Outcome Sleep Scale (MOS): Optimal Sleep Subscale
LOCF
|
0.1 scores on scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Week 21, LOCFPopulation: FAS. LOCF = Last Observation Carried Forward.
Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b.
Outcome measures
| Measure |
Pregabalin
n=135 Participants
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Week 21: Anxiety
|
-1.4 scores on scale
Standard Deviation 3.7
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
LOCF: Anxiety
|
-1.4 scores on scale
Standard Deviation 3.8
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Week 21: Depression
|
-0.8 scores on scale
Standard Deviation 4.8
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
LOCF: Depression
|
-0.7 scores on scale
Standard Deviation 4.7
|
Adverse Events
Pregabalin
Serious events: 8 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=136 participants at risk
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Drug intolerance
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Grand mal convulsion
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Headache
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Partial seizures
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Partial seizures with secondary generalization
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Syncope
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Psychotic disorder
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
Other adverse events
| Measure |
Pregabalin
n=136 participants at risk
75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Ear and labyrinth disorders
Vertigo
|
5.1%
7/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Conjunctival irritation
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Diplopia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Eyelid oedema
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Eye disorders
Vision blurred
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Gastritis
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
4/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Odynophagia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Tootheache
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Gastrointestinal disorders
Vomiting
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Asthenia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Irritability
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
General disorders
Pyrexia
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
4/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Pharyngitis
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Fall
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Investigations
Weight increased
|
14.0%
19/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Metabolism and nutrition disorders
Overweight
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dizziness
|
18.4%
25/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dysaesthesia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dysarthria
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Dyslalia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Head discomfort
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Headache
|
8.8%
12/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Paraesthesia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Somnolence
|
43.4%
59/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Tension headache
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Nervous system disorders
Tremor
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Agoraphobia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Anxiety
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Depression
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Psychiatric disorders
Insomnia
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
3/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Vascular disorders
Haematoma
|
0.74%
1/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
|
Vascular disorders
Hypertension
|
1.5%
2/136
Safety population = all subjects who took at least 1 dose of study medication. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
|
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