Trial Outcomes & Findings for A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients (NCT NCT00610155)
NCT ID: NCT00610155
Last Updated: 2021-01-22
Results Overview
BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Day 8, 22, 36
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Pregabalin Then Tramadol Then Placebo
Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Tramadol Then Placebo Then Pregabalin
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Placebo Then Pregabalin Then Tramadol
Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Pregabalin Then Placebo Then Tramadol
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Placebo Then Tramadol Then Pregabalin
Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Tramadol Then Pregabalin Then Placebo
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
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Period 1
STARTED
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4
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Period 1
COMPLETED
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1
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Period 1
NOT COMPLETED
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0
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1
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Washout Period 1 (7 Days)
STARTED
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4
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Washout Period 1 (7 Days)
COMPLETED
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Washout Period 1 (7 Days)
NOT COMPLETED
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STARTED
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COMPLETED
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NOT COMPLETED
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0
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Washout Period 2 (7 Days)
STARTED
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4
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Washout Period 2 (7 Days)
COMPLETED
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Washout Period 2 (7 Days)
NOT COMPLETED
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STARTED
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COMPLETED
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Period 3
NOT COMPLETED
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0
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Reasons for withdrawal
| Measure |
Pregabalin Then Tramadol Then Placebo
Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Tramadol Then Placebo Then Pregabalin
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Placebo Then Pregabalin Then Tramadol
Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Pregabalin Then Placebo Then Tramadol
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Placebo Then Tramadol Then Pregabalin
Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
Tramadol Then Pregabalin Then Placebo
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
|
|---|---|---|---|---|---|---|
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Period 1
Withdrawal by Subject
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0
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0
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1
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0
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0
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0
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Period 3
Adverse Event
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1
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0
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0
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0
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0
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0
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Baseline Characteristics
A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=18 Participants
Includes all participants enrolled in the study.
|
|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 8, 22, 36Population: Data not available to report, as BOLD brain activation signals in whole brain were obtained as specific Contrast Parameter Estimates (COPE) images only, as per planned analysis.
BOLD brain activation signals in whole brain was assessed using Contrast Parameter Estimates (COPE) images in response to dynamic mechanical allodynia of the affected side (DMAa), dynamic mechanical allodynia of the control side (DMAc), thermal pain (TH) and checkerboard visual stimuli (VIS).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 8, 22, 36Population: BOLD analysis set included all participants who completed all the 3 treatment periods of the study.
BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex(\[AIC\_L \],\[AIC\_R\]);left,right mid-insular cortex(\[MIC\_L\],\[MIC\_R\]);left,right posterior insular cortex(\[PIC\_L\],\[PIC\_R\]);left,right amygdala(\[Amyg\_L\],\[Amyg\_R\]);primary,secondary somatosensory cortex(\[S1\],\[S2\]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change).
Outcome measures
| Measure |
Pregabalin
n=16 Participants
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
|
Tramadol
n=16 Participants
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
|
Placebo
n=16 Participants
Matching placebo capsule orally for 7 days in either of the intervention periods.
|
|---|---|---|---|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
AIC_R
|
11.1 percent signal change
Standard Error 10.0
|
21.9 percent signal change
Standard Error 10.0
|
17.1 percent signal change
Standard Error 10.0
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
MIC_L
|
3.8 percent signal change
Standard Error 8.4
|
23.4 percent signal change
Standard Error 8.4
|
30.0 percent signal change
Standard Error 8.4
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
MIC_R
|
8.6 percent signal change
Standard Error 8.4
|
13.4 percent signal change
Standard Error 8.4
|
18.3 percent signal change
Standard Error 8.4
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
PIC_L
|
-6.8 percent signal change
Standard Error 5.2
|
-5.8 percent signal change
Standard Error 5.2
|
-0.3 percent signal change
Standard Error 5.2
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
PIC_R
|
-13.6 percent signal change
Standard Error 8.5
|
2.9 percent signal change
Standard Error 8.5
|
6.5 percent signal change
Standard Error 8.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
Amyg_L
|
-5.7 percent signal change
Standard Error 10.2
|
5.5 percent signal change
Standard Error 10.2
|
8.5 percent signal change
Standard Error 10.2
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
Amyg_R
|
-1.4 percent signal change
Standard Error 8.5
|
20.3 percent signal change
Standard Error 8.5
|
21.7 percent signal change
Standard Error 8.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
S1
|
-28.5 percent signal change
Standard Error 20.5
|
-4.1 percent signal change
Standard Error 20.5
|
-2.9 percent signal change
Standard Error 20.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
S2
|
2.5 percent signal change
Standard Error 10.8
|
-3.2 percent signal change
Standard Error 10.8
|
10.8 percent signal change
Standard Error 10.8
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
SensTHAL
|
8.0 percent signal change
Standard Error 5.4
|
16.5 percent signal change
Standard Error 5.4
|
9.6 percent signal change
Standard Error 5.4
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
MRF
|
7.0 percent signal change
Standard Error 5.0
|
6.4 percent signal change
Standard Error 5.0
|
11.7 percent signal change
Standard Error 5.0
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
NucCun
|
1.1 percent signal change
Standard Error 5.5
|
-0.9 percent signal change
Standard Error 5.5
|
12.9 percent signal change
Standard Error 5.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
PAG
|
-3.8 percent signal change
Standard Error 7.9
|
-15.3 percent signal change
Standard Error 7.9
|
2.5 percent signal change
Standard Error 7.9
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
ACC
|
-17.3 percent signal change
Standard Error 9.7
|
18.6 percent signal change
Standard Error 9.7
|
7.4 percent signal change
Standard Error 9.7
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
AIC_L
|
8.1 percent signal change
Standard Error 8.8
|
23.3 percent signal change
Standard Error 8.8
|
30.8 percent signal change
Standard Error 8.8
|
PRIMARY outcome
Timeframe: Day 8, 22, 36Population: BOLD analysis set included all participants who completed all the 3 treatment periods of the study.
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC\_L; AIC\_R; MIC\_L; MIC\_R; PIC\_L; PIC\_R; Amyg\_L; Amyg\_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).
Outcome measures
| Measure |
Pregabalin
n=16 Participants
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
|
Tramadol
n=16 Participants
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
|
Placebo
n=16 Participants
Matching placebo capsule orally for 7 days in either of the intervention periods.
|
|---|---|---|---|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
MRF
|
1.5 percent signal change
Standard Error 4.6
|
-6.6 percent signal change
Standard Error 4.6
|
-1.7 percent signal change
Standard Error 4.6
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
NucCun
|
1.0 percent signal change
Standard Error 4.9
|
-8.2 percent signal change
Standard Error 4.9
|
-1.8 percent signal change
Standard Error 4.9
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
PAG
|
1.6 percent signal change
Standard Error 7.8
|
-12.0 percent signal change
Standard Error 7.8
|
-5.0 percent signal change
Standard Error 7.8
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
AIC_R
|
-10.6 percent signal change
Standard Error 7.4
|
10.3 percent signal change
Standard Error 7.4
|
20.2 percent signal change
Standard Error 7.4
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
ACC
|
-22.3 percent signal change
Standard Error 12.0
|
-3.7 percent signal change
Standard Error 12.0
|
0.2 percent signal change
Standard Error 12.0
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
AIC_L
|
-13.5 percent signal change
Standard Error 8.0
|
18.2 percent signal change
Standard Error 8.0
|
20.2 percent signal change
Standard Error 8.0
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
MIC_L
|
-7.6 percent signal change
Standard Error 8.4
|
9.7 percent signal change
Standard Error 8.4
|
9.0 percent signal change
Standard Error 8.4
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
MIC_R
|
-9.2 percent signal change
Standard Error 6.2
|
2.8 percent signal change
Standard Error 6.2
|
0.7 percent signal change
Standard Error 6.2
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
PIC_L
|
-14.9 percent signal change
Standard Error 6.9
|
-8.1 percent signal change
Standard Error 6.9
|
0.8 percent signal change
Standard Error 6.9
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
PIC_R
|
-17.2 percent signal change
Standard Error 9.4
|
2.4 percent signal change
Standard Error 9.4
|
6.3 percent signal change
Standard Error 9.4
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
Amyg_L
|
-14.3 percent signal change
Standard Error 7.3
|
1.5 percent signal change
Standard Error 7.3
|
-3.4 percent signal change
Standard Error 7.3
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
Amyg_R
|
-10.3 percent signal change
Standard Error 9.7
|
2.0 percent signal change
Standard Error 9.7
|
-3.8 percent signal change
Standard Error 9.7
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
S1
|
-31.6 percent signal change
Standard Error 16.2
|
-4.5 percent signal change
Standard Error 16.2
|
14.6 percent signal change
Standard Error 16.2
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
S2
|
-0.4 percent signal change
Standard Error 8.3
|
9.6 percent signal change
Standard Error 8.3
|
13.5 percent signal change
Standard Error 8.3
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
SensTHAL
|
3.9 percent signal change
Standard Error 5.3
|
-2.8 percent signal change
Standard Error 5.3
|
6.7 percent signal change
Standard Error 5.3
|
PRIMARY outcome
Timeframe: Day 8, 22, 36Population: BOLD analysis set included all participants who completed all the 3 treatment periods of the study.
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC\_L; AIC\_R; MIC\_L; MIC\_R; PIC\_L; PIC\_R; Amyg\_L; Amyg\_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change).
Outcome measures
| Measure |
Pregabalin
n=16 Participants
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
|
Tramadol
n=16 Participants
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
|
Placebo
n=16 Participants
Matching placebo capsule orally for 7 days in either of the intervention periods.
|
|---|---|---|---|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
ACC
|
102.2 percent signal change
Standard Error 25.9
|
92.5 percent signal change
Standard Error 25.8
|
83.3 percent signal change
Standard Error 25.8
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
AIC_L
|
92.1 percent signal change
Standard Error 21.9
|
103.4 percent signal change
Standard Error 21.8
|
118.7 percent signal change
Standard Error 21.8
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
AIC_R
|
121.7 percent signal change
Standard Error 20.7
|
104.6 percent signal change
Standard Error 20.6
|
104.0 percent signal change
Standard Error 20.6
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
MIC_L
|
93.4 percent signal change
Standard Error 19.6
|
105.2 percent signal change
Standard Error 19.5
|
100.4 percent signal change
Standard Error 19.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
MIC_R
|
106.6 percent signal change
Standard Error 17.3
|
71.1 percent signal change
Standard Error 17.3
|
92.0 percent signal change
Standard Error 17.3
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
PIC_L
|
31.2 percent signal change
Standard Error 16.0
|
44.6 percent signal change
Standard Error 15.9
|
34.2 percent signal change
Standard Error 15.9
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
PIC_R
|
75.3 percent signal change
Standard Error 20.1
|
95.5 percent signal change
Standard Error 20.0
|
91.8 percent signal change
Standard Error 20.0
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
Amyg_L
|
29.7 percent signal change
Standard Error 16.5
|
24.9 percent signal change
Standard Error 16.5
|
36.4 percent signal change
Standard Error 16.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
Amyg_R
|
77.5 percent signal change
Standard Error 22.5
|
57.2 percent signal change
Standard Error 22.5
|
67.0 percent signal change
Standard Error 22.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
S1
|
-49.0 percent signal change
Standard Error 30.2
|
37.7 percent signal change
Standard Error 30.1
|
27.7 percent signal change
Standard Error 30.1
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
S2
|
73.6 percent signal change
Standard Error 21.2
|
94.6 percent signal change
Standard Error 21.2
|
74.5 percent signal change
Standard Error 21.2
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
SensTHAL
|
19.4 percent signal change
Standard Error 12.1
|
0.8 percent signal change
Standard Error 12.1
|
10.4 percent signal change
Standard Error 12.1
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
MRF
|
34.3 percent signal change
Standard Error 14.7
|
25.5 percent signal change
Standard Error 14.6
|
37.7 percent signal change
Standard Error 14.6
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
NucCun
|
38.7 percent signal change
Standard Error 11.5
|
27.7 percent signal change
Standard Error 11.5
|
40.5 percent signal change
Standard Error 11.5
|
|
Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
PAG
|
63.3 percent signal change
Standard Error 15.9
|
53.6 percent signal change
Standard Error 15.8
|
44.6 percent signal change
Standard Error 15.8
|
PRIMARY outcome
Timeframe: Day 8, 22, 36Population: For VIS, based on preliminary analysis results, it was not considered significant to collect data according to Investigator's opinion.
BOLD brain activation signals in pre-defined ROI in response to checkerboard visual stimuli (flashing at 2 Hz). ROI were ACC; AIC\_L; AIC\_R; MIC\_L; MIC\_R; PIC\_L; PIC\_R; Amyg\_L; Amyg\_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 8, 22, 36Population: Data was not analyzed since these methods were not technically robust enough to make any clear conclusions.
Continuous ASL sequence fMRI imaging modality assessing brain activation signals across the whole brain and in defined ROI to assess effects of evoked pain along with changes in regional cerebral blood flow (rCBF). ROI were ACC; AIC\_L; AIC\_R; MIC\_L; MIC\_R; PIC\_L; PIC\_R; Amyg\_L; Amyg\_R; S1; S2; SensTHAL; MRF; NucCun; PAG.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8, 22, 36Population: Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8, 22, 36Population: Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.
BDI is a 21 item participant rated inventory evaluating depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicate more depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8, 22, 36Population: Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.
Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant report how they feel "right now at this moment" for state anxiety and how they "generally" feel for trait anxiety. The "state" items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very much so). The "trait" items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 20-80 for each scale. Higher scores indicate more impaired participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 8, 22, 36Population: Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores indicate greater extent of pain catastrophizing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -7), Day 8, 22, 36Population: Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.
NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicate a greater intensity of pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day -35 through Day 36Population: FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated.
Outcome measures
| Measure |
Pregabalin
n=18 Participants
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
|
Tramadol
n=17 Participants
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
|
Placebo
n=18 Participants
Matching placebo capsule orally for 7 days in either of the intervention periods.
|
|---|---|---|---|
|
Daily Pain Score
Last 7 days
|
5.57 units on a scale
Standard Error 0.371
|
5.28 units on a scale
Standard Error 0.370
|
6.40 units on a scale
Standard Error 0.370
|
|
Daily Pain Score
Last 3 days
|
5.46 units on a scale
Standard Error 0.466
|
5.10 units on a scale
Standard Error 0.454
|
6.33 units on a scale
Standard Error 0.454
|
SECONDARY outcome
Timeframe: Day 8, 22, 36Population: FAS included all the participants who were enrolled in the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants answered: "Please rate your pain from 0-10 that best describes the intensity of pain right now". PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Pregabalin
n=17 Participants
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
|
Tramadol
n=17 Participants
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
|
Placebo
n=17 Participants
Matching placebo capsule orally for 7 days in either of the intervention periods.
|
|---|---|---|---|
|
Present Pain Intensity Score (PPIS)
|
5.54 units on a scale
Standard Error 0.552
|
4.13 units on a scale
Standard Error 0.551
|
5.83 units on a scale
Standard Error 0.551
|
SECONDARY outcome
Timeframe: Day -35Population: Data for this outcome measure was plotted against treatment for each participant as per planned analysis but not statistically summarized for analysis.
DN4 questionnaire provides a simple diagnosis of Neuropathic pain (NeP) by asking for yes/no answers to 4 questions (10 sub questions in total). Each question was scored on a scale of 0 (No) and 1 (Yes). Total score was calculated as sum of the 10 individual questions. Total score range 0-10, higher score indicated more neuropathic pain.
Outcome measures
Outcome data not reported
Adverse Events
Pregabalin
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Tramadol
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregabalin
n=17 participants at risk
Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
|
Tramadol
n=17 participants at risk
Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
|
Placebo
n=18 participants at risk
Matching placebo capsule orally for 7 days in either of the intervention periods.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
23.5%
4/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Eye disorders
Vision blurred
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Dry mouth
|
17.6%
3/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
47.1%
8/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
23.5%
4/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
General disorders
Fatigue
|
17.6%
3/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
35.3%
6/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
General disorders
Feeling hot
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
General disorders
Malaise
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
General disorders
Thirst
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Infections and infestations
Nasopharyngitis
|
17.6%
3/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Infections and infestations
Tooth abscess
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
17.6%
3/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Balance disorder
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Clumsiness
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Dizziness
|
41.2%
7/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
47.1%
8/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
11.1%
2/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Headache
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Nervous system disorders
Somnolence
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
23.5%
4/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Psychiatric disorders
Confusional state
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Psychiatric disorders
Libido decreased
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Psychiatric disorders
Loss of libido
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Psychiatric disorders
Mood swings
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.6%
1/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
11.8%
2/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
29.4%
5/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
5.9%
1/17
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
0.00%
0/18
The same event may appear as both an AE and a SAE. But, distinct events are presented. An event may be categorized as serious in 1 subject; as nonserious in another subject or 1 subject may have experienced both serious, nonserious events in study.'At risk population'=who received study treatments in different interventions;PGB=17,TMD=17,PBO=18.
|
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