Trial Outcomes & Findings for A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin (NCT NCT00892008)
NCT ID: NCT00892008
Last Updated: 2021-01-25
Results Overview
Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.
Recruitment status
COMPLETED
Target enrollment
2278 participants
Primary outcome timeframe
Baseline through Final Visit (Week 4)
Results posted on
2021-01-25
Participant Flow
Phase 4 nationwide post-marketing surveillance study conducted between Sep 2006 and Aug 2008.
Participant milestones
| Measure |
Pregabalin
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Overall Study
STARTED
|
2278
|
|
Overall Study
COMPLETED
|
1713
|
|
Overall Study
NOT COMPLETED
|
565
|
Reasons for withdrawal
| Measure |
Pregabalin
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Lost to Follow-up
|
142
|
|
Overall Study
Other
|
378
|
|
Overall Study
Adverse Event
|
37
|
Baseline Characteristics
A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
Baseline characteristics by cohort
| Measure |
Pregabalin
n=2278 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Age, Customized
18-44 years
|
582 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
1054 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
451 participants
n=5 Participants
|
|
Age, Customized
unspecified
|
191 participants
n=5 Participants
|
|
Sex/Gender, Customized
female
|
1324 participants
n=5 Participants
|
|
Sex/Gender, Customized
male
|
932 participants
n=5 Participants
|
|
Sex/Gender, Customized
unspecified
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Final Visit (Week 4)Population: Safety population: all subjects who took at least 1 dose of study medication.
Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken.
Outcome measures
| Measure |
Pregabalin
n=2278 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
breast cancer stage III (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
metastases to central nervous system (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
metastatic neoplasm (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Nervous System Disorders
|
233 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
balance disorder (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dizziness (unspecified)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Musculoskeletal and Connective Tissue Disorders
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
muscular weakness (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
myalgia (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Neoplasms Benign, Malignant and Unspecified
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Cardiac Disorders
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
palpitations (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Ear and Labyrinth Disorders
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
ear disorder (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
vertigo (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
vertigo (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Gastrointestinal Disorders
|
44 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
abdominal discomfort (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
abdominal distension (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
abdominal pain (upper)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
constipation (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
constipation (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
diarrhoea (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
diarrhoea (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dry mouth (mild)
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dry mouth (moderate)
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dyspepsia (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
epigastric discomfort (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
nausea (mild)
|
10 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
nausea (moderate)
|
13 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
nausea (severe)
|
4 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
vomiting (mild)
|
8 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
vomiting (moderate)
|
4 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
vomiting (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
General Disorders & Administration Site Conditions
|
20 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
asthenia (mild)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
asthenia (moderate)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
asthenia (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
fatigue (moderate)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
ill-defined disorder (mild)
|
5 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
ill-defined disorder (moderate)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
ill-defined disorder (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
irritability (mild)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
irritability (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
multi-organ failure (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
oedema peripheral (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
oedema peripheral (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
pyrexia (mild)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Hepatobiliary Disorders
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
jaundice (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Infections and Infestations
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
bronchopneumonia (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
pneumonia (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Investigations
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
weight increased (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Metabolism and Nutrition Disorders
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
anorexia (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
hypoglycemia (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
increased appetite (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dizziness (mild)
|
79 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dizziness (moderate)
|
47 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dizziness (severe)
|
8 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
headache (mild)
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
headache (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
hypersomnia (mild)
|
5 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
hypersomnia (moderate)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
incoherent (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
neuralgia (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
paraesthesia (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
sedation (moderate)
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
sedation (severe)
|
2 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
somnolence (unspecified)
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
somnolence (mild)
|
62 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
somnolence (moderate)
|
24 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
somnolence (severe)
|
4 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
syncope (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
syncope (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
tremor (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Psychiatric Disorders
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
abnormal dreams (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
confusional state (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
insomnia (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Reproductive and Breast Disorders
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
ejaculation disorder (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Respiratory, Thoracic and Mediastinal Disorders
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dyspnoea (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
dyspnoea exertional (mild)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
snoring (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Skin and Subcutaneous Tissue Disorders
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
rash generalized (severe)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
Vascular Disorders
|
3 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
hypertension (unspecified)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
hypotension (moderate)
|
1 participants
|
|
Number and Severity of Adverse Events (All Causalities); Baseline to Final Visit (Week 4)
pallor (mild)
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Safety population: all subjects who took at least one dose of study medication.
Discontinuations due to adverse events by MedDRA system organ class and preferred term.
Outcome measures
| Measure |
Pregabalin
n=2278 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Discontinuations Due to Adverse Events
Cardiac Disorders: palpitations
|
1 participants
|
|
Discontinuations Due to Adverse Events
Ear and Labyrinth Disorders: vertigo
|
1 participants
|
|
Discontinuations Due to Adverse Events
Gastrointestinal Disorders: nausea
|
5 participants
|
|
Discontinuations Due to Adverse Events
Gastrointestinal Disorders: vomiting
|
3 participants
|
|
Discontinuations Due to Adverse Events
General/ Administrative Site Conditions: asthenia
|
2 participants
|
|
Discontinuations Due to Adverse Events
Nervous System Disorders: somnolence
|
26 participants
|
|
Discontinuations Due to Adverse Events
Resp., Thoracic & Mediastinal Disorders: snoring
|
1 participants
|
|
Discontinuations Due to Adverse Events
Vascular Disorders: hypertension
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N = number of subjects with a Visual Analog Scale (VAS) pain score at Baseline Visit.
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline.
Outcome measures
| Measure |
Pregabalin
n=1558 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) Score
Second Visit (n=1472)
|
3.5 scores on scale
Standard Deviation 1.7
|
|
Change From Baseline in Visual Analogue Scale (VAS) Score
Final Visit (n=1126)
|
5.1 scores on scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, Second Visit (Week ≥ 2)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit .
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Mild Pain (n=25); 2nd Visit: Mild Pain
|
22 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Mild Pain (n= 25); 2nd Visit: Moderate Pain
|
0 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Mild Pain (n= 25); 2nd Visit: Severe Pain
|
0 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL:Mild Pain (n= 25); 2nd Visit: Worst Poss. Pain
|
0 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Mild Pain (n= 25); 2nd Visit: Missing
|
3 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Moderate Pain (n=450); 2nd Visit: Mild Pain
|
300 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Moderate Pain (n=450): 2nd Visit: Mod Pain
|
115 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Moderate Pain (n=450); 2nd Visit: Severe Pain
|
2 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Mod Pain (n=450); 2nd Visit: Worst Poss. Pain
|
0 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Moderate Pain (n=450); 2nd Visit: Missing
|
33 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Severe Pain (n=985); 2nd Visit: Mild Pain
|
348 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Severe Pain (n=985); 2nd Visit: Moderate Pain
|
533 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Severe Pain (n=985) ; 2nd Visit: Severe Pain
|
59 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Sev Pain (n=985); 2nd Visit: Worst Poss. pain
|
0 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Severe Pain (n=985); 2nd Visit: Missing
|
45 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Worst Poss. Pain (n=98) ; 2nd Visit: Mild Pain
|
18 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Worst Poss. Pain (n=98); 2nd Visit: Mod Pain
|
49 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Worst Poss. Pain (n=98); 2nd Visit: Sev Pain
|
25 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL:Wrst Poss Pain (n=98); 2nd Visit: Wrst Poss. Pn
|
1 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Worst Poss. Pain (n=98) ; 2nd Visit: Missing
|
5 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Missing (n=45); 2nd Visit: Mild Pain
|
3 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Missing (n=45) ; 2nd Visit: Moderate Pain
|
1 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Missing (n=45) ; 2nd Visit: Severe Pain
|
3 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Missing (n=45) ; 2nd Visit: Worst Poss. Pain
|
0 participants
|
|
VAS Pain Score at Baseline (BL) and Second Visit
BL: Missing (n=45); 2nd Visit: Missing
|
38 participants
|
SECONDARY outcome
Timeframe: Baseline, Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
VAS Pain Score at Baseline and Final Visit
BL: Mild Pain (n=25); Final Visit: Mild Pain
|
12 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Mild Pain (n=25); Final Visit: Moderate Pain
|
0 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Mild Pain (n=25); Final Visit: Severe Pain
|
0 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Mild Pain (n=25); Final Visit: Missing
|
13 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Moderate Pain (n=450); Final Visit: Mild Pain
|
272 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Moderate Pain (n=450); Final Visit: Mod. Pain
|
19 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Moderate Pain (n=450); Final Visit: Sev. Pain
|
1 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Moderate Pain (n=450); Final Visit: Missing
|
158 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Severe Pain (n=985); Final Visit: Mild Pain
|
602 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Severe Pain (n=985); Final Visit: Mod. Pain
|
134 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Severe Pain (n=985); Final Visit: Severe Pain
|
6 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Severe Pain (n=985); Final Visit: Missing
|
243 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Worst Poss. Pain (n=98); Final Vst: Mild Pain
|
54 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Worst Poss. Pain (n=98); Final Vst: Mod Pain
|
25 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Worst Poss. Pain (n=98); Final Visit: Sev Pain
|
1 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Worst Poss. Pain (n=98); Final Visit: Missing
|
18 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Missing (n=45); Final Visit: Mild Pain
|
4 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Missing (n=45); Final Visit: Moderate Pain
|
1 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Missing (n=45); Final Visit: Severe Pain
|
1 participants
|
|
VAS Pain Score at Baseline and Final Visit
BL: Missing (n=45); Final Visit: Missing
|
39 participants
|
SECONDARY outcome
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=272); Final Vst: Excellent
|
209 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=272); Final Vst: Very Good
|
6 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=272); Final Visit: Good
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=272); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=272); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=272); Final Visit: Missing
|
55 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=803); Final Vst: Excellent
|
307 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=803); Final Vst: Very Good
|
421 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=803); Final Visit: Good
|
10 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=803); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=803); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=803); Final Visit: Missing
|
65 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=438); Final Visit: Excellent
|
27 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=438); Final Visit: Very Good
|
267 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=438); Final Visit: Good
|
119 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=438); Final Visit: Fair
|
4 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=438); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=438); Final Visit: Missing
|
21 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=71); Final Visit: Excellent
|
7 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=71); Final Visit: Very Good
|
22 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=71); Final Visit: Good
|
30 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=71); Final Visit: Fair
|
3 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=71); Final Visit: Poor
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=71); Final Visit: Missing
|
8 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=7); Final Visit: Excellent
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=7); Final Visit: Very Good
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=7); Final Visit: Good
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=7); Final Visit: Fair
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=7); Final Visit: Poor
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=7); Final Visit: Missing
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=12); Final Visit: Excellent
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=12); Final Visit: Very Good
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=12); Final Visit: Good
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=12); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=12); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=12); Final Visit: Missing
|
12 participants
|
SECONDARY outcome
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=260); Final Vst: Excell
|
201 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excell (n=260) ; Final Vst:Very Good
|
11 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=260); Final Visit: Good
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=260) ; Final Visit: Fair
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=260) ; Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Excellent (n=260); Final Visit: Missing
|
47 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=778); Final Visit: Excell
|
297 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=778); Final Vst: Very Good
|
394 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=778); Final Visit: Good
|
13 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=778); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=778); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Very Good (n=778); Final Visit: Missing
|
73 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=454); Final Visit: Excellent
|
35 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=454); Final Visit: Very Good
|
263 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=454); Final Visit: Good
|
130 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=454); Final Visit: Fair
|
4 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=454); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Good (n=454); Final Visit: Missing
|
22 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=81); Final Visit: Excellent
|
9 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=81); Final Visit: Very Good
|
23 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=81); Final Visit:: Good
|
31 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=81); Final Visit: Fair
|
9 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=81); Final Visit: Poor
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Fair (n=81); Final Visit: Missing
|
8 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=12); Final Visit: Excellent
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=12); Final Visit: Very Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=12); Final Visit: Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=12); Final Visit: Fair
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit::Poor (n=12); Final Visit: Poor
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Poor (n=12); Final Visit: Missing
|
3 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=18); Final Visit: Excellent
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=18); Final Visit: Very Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=18); Final Visit: Good
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=18); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=18); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Treatment Satisfaction at the Second and Final Visits
2nd Visit: Missing (n=18); Final Visit: Missing
|
15 participants
|
SECONDARY outcome
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=279); Final Visit: Excell
|
217 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=279); Final Vst: Very Good
|
8 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=279); Final Visit: Good
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=279); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=279); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=279); Final Visit: Missing
|
53 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=813); Final Visit: Excell
|
298 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=813); Final Vst: Very Good
|
437 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=813); Final Visit: Good
|
10 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=813); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=813); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=813); Final Visit: Missing
|
68 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=418); Final Visit: Excellent
|
19 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=418); Final Visit: Very Good
|
258 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=418); Final Visit: Good
|
115 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=418); Final Visit: Fair
|
5 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=418); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=418); Final Visit: Missing
|
21 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=66); Final Visit: Excellent
|
4 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=66); Final Visit: Very Good
|
20 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=66); Final Visit: Good
|
28 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=66); Final Visit: Fair
|
5 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=66); Final Visit: Poor
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=66); Final Visit: Missing
|
7 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=7); Final Visit: Excellent
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=7); Final Visit: Very Good
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=7); Final Visit: Good
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=7); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=7); Final Visit: Poor
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=7); Final Visit: Missing
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=20); Final Visit: Excellent
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=20); Final Visit: Very Good
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=20); Final Visit: Good
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=20); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=20); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=20); Final Visit: Missing
|
19 participants
|
SECONDARY outcome
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=264); Final Visit: Excell
|
206 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=264); Final Vst: Very Good
|
8 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=264); Final Visit: Good
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=264); Final Visit: Fair
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=264); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Excellent (n=264); Final Visit: Missing
|
50 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=775); Final Visit: Excell
|
286 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=775); Final Vst: Very Good
|
405 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=775); Final Visit: Good
|
12 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=775); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=775); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Very Good (n=775); Final Visit: Missing
|
71 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=450); Final Visit: Excellent
|
34 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=450): Final Visit: Very Good
|
266 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=450); Final Visit: Good
|
127 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=450); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=450); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Good (n=450); Final Visit: Missing
|
22 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=75); Final Visit: Excellent
|
6 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=75); Final Visit: Very Good
|
21 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=75); Final Visit: Good
|
32 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=75); Final Visit: Fair
|
10 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=75); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Fair (n=75); Final Visit: Missing
|
6 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=12); Final Visit: Excellent
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit :Poor (n=12); Final Visit: Very Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=12); Final Visit: Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=12); Final Visit: Fair
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=12); Final Visit: Poor
|
3 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Poor (n=12); Final Visit: Missing
|
4 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=27); Final Visit: Excellent
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=27); Final Visit: Very Good
|
3 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=27); Final Visit: Good
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=27); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=27); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Efficacy at Second and Final Visit
2nd Visit: Missing (n=27); Final Visit: Missing
|
23 participants
|
SECONDARY outcome
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Excellent (n=309); Final Visit: Excell
|
237 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Excellent (n=309); Final Vst: Very Good
|
12 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Excellent (n=309); Final Visit: Good
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Excellent (n=309); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Excellent (n=309); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Excellent (n=309); Final Visit: Missing
|
60 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Very Good (n=764); Final Visit: Excell
|
255 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Very Good (n=764); Final Vst:Very Good
|
431 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Very Good (n=764); Final Visit: Good
|
9 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Very Good (n=764); Final Visit: Fair
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Very Good (n=764); Final Visit: Poor
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Very Good (n=764); Final Visit: Missing
|
67 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Good (n=436); Final Visit: Excellent
|
24 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Good (n=436); Final Visit: Very Good
|
254 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Good (n=436); Final Visit: Good
|
135 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Good (n=436); Final Visit: Fair
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Good (n=436); Final Visit: Poor
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Good (n=436); Final Visit: Missing
|
21 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Fair (n=67); Final Visit: Excellent
|
6 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Fair (n=67); Final Visit: Very Good
|
19 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Fair (n=67); Final Visit: Good
|
30 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Fair (n=67); Final Visit: Fair
|
5 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Fair (n=67); Final Visit: Poor
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Fair (n=67); Final Visit: Missing
|
6 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Poor (n=6); Final Visit: Excellent
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Poor (n=6); Final Visit: Very Good
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Poor (n=6); Final Visit: Good
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Poor (n=6); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Poor (n=6); Final Visit: Poor
|
3 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Poor (n=6); Final Visit: Missing
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Missing (n=21); Final Visit: Excellent
|
1 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Missing (n=21); Final Visit: Very Good
|
2 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Missing (n=21); Final Visit: Good
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Missing (n=21); Final Visit: Fair
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Missing (n=21); Final Visit: Poor
|
0 participants
|
|
Physician's Clinical Global Impression (CGI) on Tolerability at Second and Final Viist
2nd Visit: Missing (n=21); Final Visit: Missing
|
18 participants
|
SECONDARY outcome
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)Population: Intent to treat (ITT) population: a subset of the safety population who underwent Baseline assessment, received study drug for at least 2 weeks, and had at least 1 follow-up visit. N=number of subjects in ITT population.
Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit.
Outcome measures
| Measure |
Pregabalin
n=1603 Participants
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Excellent (n=278); Final Visit: Excell
|
213 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Excellent (n=278); Final Vst: Very Good
|
14 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Excellent (n=278); Final Visit: Good
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Excellent (n=278); Final Visit: Fair
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Excellent (n=278); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Excellent (n=278); Final Visit: Missing
|
51 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Very Good (n=750); Final Visit: Excell
|
257 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Very Good (n=750); Final Vst: Very Good
|
415 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Very Good (n=750); Final Visit: Good
|
13 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Very Good (n=750); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Very Good (n=750); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Very Good (n=750); Final Visit: Missing
|
64 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Good (n=465); Final Visit: Excellent
|
27 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Good (n=465); Final Visit: Very Good
|
255 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Good (n=465); Final Visit: Good
|
151 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Good (n=465); Final Visit: Fair
|
4 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Good (n=465); Final Visit: Poor
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Good (n=465); Final Visit: Missing
|
26 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Fair (n=71); Final Visit: Excellent
|
8 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Fair (n=71); Final Visit: Very Good
|
18 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Fair (n=71); Final Visit: Good
|
31 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Fair (n=71); Final Visit: Fair
|
7 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Fair (n=71); Final Visit: Poor
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Fair (n=71); Final Visit: Missing
|
6 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Poor (n=11); Final Visit: Excellent
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Poor (n=11); Final Visit: Very Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Poor (n=11); Final Visit: Good
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Poor (n=11); Final Visit: Fair
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Poor (n=11); Final Visit: Poor
|
3 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Poor (n=11); Final Visit: Missing
|
4 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Missing (n=28); Final Visit: Excellent
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Missing (n=28); Final Visit: Very Good
|
2 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Missing (n=28); Final Visit: Good
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Missing (n=28); Final Visit: Fair
|
1 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Missing (n=28); Final Visit: Poor
|
0 participants
|
|
Patient's Clinical Global Impression (CGI) of Tolerability at Second and Final Visit
2nd Visit: Missing (n=28); Final Visit: Missing
|
24 participants
|
Adverse Events
Pregabalin
Serious events: 7 serious events
Other events: 345 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=2278 participants at risk
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
General disorders
Asthenia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Multi-organ failure
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Infections and infestations
Bronchopneumonia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Infections and infestations
Pneumonia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Dizziness
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Neuralgia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Sedation
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Somnolence
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
Other adverse events
| Measure |
Pregabalin
n=2278 participants at risk
75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
|
|---|---|
|
Cardiac disorders
Palpitations
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Ear and labyrinth disorders
Ear disorder
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Constipation
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Dry mouth
|
0.26%
6/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Nausea
|
1.2%
27/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
13/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Asthenia
|
0.18%
4/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Fatigue
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Ill-defined disorder
|
0.35%
8/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Irritability
|
0.13%
3/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Oedema peripheral
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
General disorders
Pyrexia
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Hepatobiliary disorders
Jaundice
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Investigations
Weight increased
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Balance disorder
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Dizziness
|
5.9%
135/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Headache
|
0.18%
4/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Hypersomnia
|
0.31%
7/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Incoherent
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Paraesthesia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Sedation
|
0.18%
4/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Somnolence
|
4.0%
92/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Syncope
|
0.09%
2/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Nervous system disorders
Tremor
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Psychiatric disorders
Abnormal dreams
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Psychiatric disorders
Confusional state
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Psychiatric disorders
Insomnia
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Vascular disorders
Hypertension
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Vascular disorders
Hypotension
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
|
Vascular disorders
Pallor
|
0.04%
1/2278 • Adverse events: Baseline through end of study (>= Week 4); serious adverse events: Baseline through and including 28 calendar days after the last administration of study medication (last administration was up to Week 4).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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