Trial Outcomes & Findings for Adolescent Fibromyalgia Study (NCT NCT01020474)
NCT ID: NCT01020474
Last Updated: 2021-01-28
Results Overview
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
Week 15
Results posted on
2021-01-28
Participant Flow
A total of 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers.
This study consisted of 4 phases, screening (1 Week), dose optimization (3 Weeks), fixed dose (12 Weeks) and follow-up (1 Week).
Participant milestones
| Measure |
Pregabalin
Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
COMPLETED
|
44
|
36
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
Reasons for withdrawal
| Measure |
Pregabalin
Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Other Reasons
|
1
|
1
|
|
Overall Study
Insufficient Clinical Response
|
0
|
3
|
Baseline Characteristics
Adolescent Fibromyalgia Study
Baseline characteristics by cohort
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=53 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
14.7 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 15Population: The full analysis set (FAS) population consists of all randomized participants who received at least one dose of study medication.
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=51 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Change From Baseline to Week 15 in Mean Pain Diary Score
|
-1.60 Units on a scale
Standard Error 0.32
|
-0.94 Units on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication. Last observation carried forward (LOCF) for participants with missing Week 15 mean pain score, i.e., the endpoint mean pain score.
Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=50 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
|
-1.13 Units on a scale
Standard Error 0.30
|
-0.94 Units on a scale
Standard Error 0.31
|
SECONDARY outcome
Timeframe: Baseline to Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication.
Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=51 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 1 (N= 52, 49)
|
-0.48 Units on a scale
Standard Error 0.25
|
-0.41 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 2 (N= 54, 47)
|
-1.11 Units on a scale
Standard Error 0.25
|
-0.48 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 3 (N= 52, 44)
|
-1.27 Units on a scale
Standard Error 0.25
|
-0.45 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 4 (N= 50, 46)
|
-1.45 Units on a scale
Standard Error 0.25
|
-0.55 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 5 (N= 49, 44)
|
-1.27 Units on a scale
Standard Error 0.25
|
-0.59 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 6 (N= 49, 44)
|
-1.47 Units on a scale
Standard Error 0.25
|
-0.51 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 7 (N= 48, 42)
|
-1.67 Units on a scale
Standard Error 0.25
|
-0.77 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 8 (N= 46, 44)
|
-1.65 Units on a scale
Standard Error 0.25
|
-0.59 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 9 (N= 46, 42)
|
-1.61 Units on a scale
Standard Error 0.26
|
-0.66 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 10 (N= 45, 40)
|
-1.82 Units on a scale
Standard Error 0.26
|
-0.85 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 11 (N= 44, 38)
|
-1.93 Units on a scale
Standard Error 0.26
|
-1.07 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 12 (N= 43, 34)
|
-1.75 Units on a scale
Standard Error 0.26
|
-0.78 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 13 (N= 42, 33)
|
-1.75 Units on a scale
Standard Error 0.27
|
-1.01 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 14 (N= 41, 34)
|
-2.01 Units on a scale
Standard Error 0.27
|
-1.11 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Week 15 (N= 35, 33)
|
-1.90 Units on a scale
Standard Error 0.28
|
-1.16 Units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Baseline to Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication.
Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=51 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 1 (N= 52, 49)
|
-0.52 Units on a scale
Standard Error 0.25
|
-0.30 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 2 (N= 54, 47)
|
-0.84 Units on a scale
Standard Error 0.25
|
-0.65 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 3 (N= 52, 44)
|
-0.89 Units on a scale
Standard Error 0.25
|
-0.44 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 4 (N= 50, 46)
|
-1.03 Units on a scale
Standard Error 0.25
|
-0.54 Units on a scale
Standard Error 0.26
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 5 (N= 49, 44)
|
-0.99 Units on a scale
Standard Error 0.25
|
-0.61 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 6 (N= 49, 44)
|
-1.18 Units on a scale
Standard Error 0.25
|
-0.54 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 7 (N= 48, 42)
|
-1.30 Units on a scale
Standard Error 0.25
|
-0.81 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 8 (N= 46, 44)
|
-1.43 Units on a scale
Standard Error 0.25
|
-0.42 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 9 (N= 46, 42)
|
-1.38 Units on a scale
Standard Error 0.26
|
-0.81 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 10 (N= 45, 40)
|
-1.43 Units on a scale
Standard Error 0.26
|
-0.66 Units on a scale
Standard Error 0.27
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 11 (N= 44, 38)
|
-1.39 Units on a scale
Standard Error 0.26
|
-0.95 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 12 (N= 43, 34)
|
-1.38 Units on a scale
Standard Error 0.26
|
-0.77 Units on a scale
Standard Error 0.28
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 13 (N= 42, 33)
|
-1.34 Units on a scale
Standard Error 0.27
|
-1.00 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 14 (N= 41, 34)
|
-1.36 Units on a scale
Standard Error 0.27
|
-0.94 Units on a scale
Standard Error 0.29
|
|
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Week 15 (N= 35, 33)
|
-1.25 Units on a scale
Standard Error 0.28
|
-1.08 Units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication. Baseline observation carried forward (BOCF) for participants with missing Week 15 mean pain score.
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=53 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
|
-1.64 Units on a scale
Standard Error 0.31
|
-0.77 Units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication. Modified baseline observation carried forward (mBOCF) for participants with missing Week 15 mean pain score.
At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=49 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
|
42.6 percentage of participants
|
38.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication. mBOCF for participants with missing Week 15 mean pain score.
At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=49 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
|
20.4 percentage of participants
|
10.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 15Population: The FAS population consists of all randomized participants who received at least one dose of study medication.
Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Pregabalin
n=49 Participants
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=44 Participants
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
Very much improved
|
16.3 percentage of participants
|
2.3 percentage of participants
|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
Much improved
|
36.7 percentage of participants
|
27.3 percentage of participants
|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
Minimally improved
|
22.4 percentage of participants
|
27.3 percentage of participants
|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
No change
|
18.4 percentage of participants
|
38.6 percentage of participants
|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
Minimally worse
|
6.1 percentage of participants
|
2.3 percentage of participants
|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
Much worse
|
0 percentage of participants
|
2.3 percentage of participants
|
|
Proportion of Patient Global Impression Change (PGIC) at Week 15
Very much worse
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Pregabalin
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=54 participants at risk
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=53 participants at risk
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
1.9%
1/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
0.00%
0/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Psychiatric disorders
Major depression
|
1.9%
1/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
0.00%
0/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
Other adverse events
| Measure |
Pregabalin
n=54 participants at risk
Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
|
Placebo
n=53 participants at risk
Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
1/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
1.9%
1/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
2/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
12/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
9.4%
5/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
7.5%
4/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
General disorders
Fatigue
|
14.8%
8/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
7.5%
4/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
General disorders
Pyrexia
|
7.4%
4/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
7.5%
4/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
7.5%
4/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
0.00%
0/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Investigations
Weight increased
|
16.7%
9/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
0.00%
0/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
1.9%
1/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
7.5%
4/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
9.4%
5/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
4/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
0.00%
0/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Nervous system disorders
Balance disorder
|
5.6%
3/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
0.00%
0/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Nervous system disorders
Dizziness
|
29.6%
16/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
13.2%
7/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Nervous system disorders
Headache
|
18.5%
10/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
18.9%
10/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Nervous system disorders
Migraine
|
3.7%
2/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Nervous system disorders
Somnolence
|
9.3%
5/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
3.8%
2/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
7.5%
4/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
2/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
5.7%
3/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
4/54 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
3.8%
2/53 • Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).
Participants are only counted once per treatment for each event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER