Trial Outcomes & Findings for Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib. (NCT NCT00484718)
NCT ID: NCT00484718
Last Updated: 2021-04-14
Results Overview
The severity of arthritis pain in participant's signal knee at the time of the visit was assessed using an 11-point NRS, ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain.
TERMINATED
PHASE4
6 participants
Baseline, Week 12
2021-04-14
Participant Flow
Total 6 participants were randomized to receive 1 of 6 possible treatment sequences of ABC, ACB. BAC, BCA, CAB, CBA (where: A=placebo, B=celecoxib, C=oxycodone) in treatment periods 1, 2 and 3 (each 2-week treatment period was separated by a 2-week washout period).
Participant milestones
| Measure |
Placebo Then Celecoxib Then Oxycodone
Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Days 1 to 14 of treatment period 1 (participants received placebo from Days 1 to 84 in 3 treatment periods \[14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period\]), then in treatment period 2 participants received celecoxib 100 milligram (mg) (200 milligram per day \[mg/day\]) capsule orally, twice daily on Days 1-14 followed by oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
|
Placebo Then Oxycodone Then Celecoxib
Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Days 1 to 14 of treatment period 1 (participants received placebo from Days 1 to 84 in 3 treatment periods \[14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period\]), then in treatment period 2 participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally twice daily on Days 1-14 followed by celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
|
Celecoxib Then Placebo Then Oxycodone
Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 of treatment period 1 then, in treatment period 2 participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 (participants received placebo from Days 1 to 84 in 3 treatment periods \[14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period\]), followed by oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
|
Celecoxib Then Oxycodone Then Placebo
Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 of treatment period 1, then in treatment period 2 participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14, followed by placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 of treatment period 3 (participants received placebo from Days 1 to 84 in 3 treatment periods \[14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period\]). Each 2-week treatment period was separated by a 2-week washout period.
|
Oxycodone Then Placebo Then Celecoxib
Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 1 then, in treatment period 2 participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 (participants received placebo from Days 1 to 84 in 3 treatment periods \[14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period\]), followed by celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 3. Each 2-week treatment period was separated by a 2-week washout period.
|
Oxycodone Then Celecoxib Then Placebo
Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in treatment period 1 then, in treatment period 2 participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14, followed by placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 14 of treatment period 3 (participants received placebo from Days 1 to 84 in 3 treatment periods \[14 days prior to each treatment periods {i.e. during 2-week washout period}, and Day 1-14 in each treatment period\]). Each 2-week treatment period was separated by a 2-week washout period.
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|---|---|---|---|---|---|---|
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Treatment Period 1 (2 Weeks)
STARTED
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1
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1
|
1
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1
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1
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1
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Treatment Period 1 (2 Weeks)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Treatment Period 1 (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
|
|
Washout Period (2 Weeks)
STARTED
|
1
|
1
|
1
|
1
|
1
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1
|
|
Washout Period (2 Weeks)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
|
|
Treatment Period 2 (2 Weeks)
STARTED
|
1
|
1
|
1
|
1
|
1
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1
|
|
Treatment Period 2 (2 Weeks)
COMPLETED
|
1
|
1
|
1
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1
|
1
|
1
|
|
Treatment Period 2 (2 Weeks)
NOT COMPLETED
|
0
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0
|
0
|
0
|
0
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0
|
|
Treatment Period 3 (2 Weeks)
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Treatment Period 3 (2 Weeks)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Treatment Period 3 (2 Weeks)
NOT COMPLETED
|
0
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0
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0
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0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
Baseline characteristics by cohort
| Measure |
All Participants
n=6 Participants
All randomized participants who received placebo matched to celecoxib and oxycodone, celecoxib 100 mg and oxycodone 20 mg orally, twice daily in one of the 6 treatment sequences in each of three treatment periods.
|
|---|---|
|
Age, Continuous
|
62.5 Years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
The severity of arthritis pain in participant's signal knee at the time of the visit was assessed using an 11-point NRS, ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
The severity of arthritis pain in participant's signal knee was assessed using a 100-millimeter (mm) VAS ranging from 0 mm = no pain and 100 mm = most severe pain. Higher score indicate more pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The index consists of 24 questions (5 pain, 2 stiffness, and 17 physical function). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. The WOMAC pain subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse pain. Pain subscale total score ranges from 0 to 20, with higher scores indicating worse pain.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in in the study joint during past 48 hours. The WOMAC physical function subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse physical function. Physical function subscale scores range from 0 to 68, where higher scores indicated more difficulty in performing daily activities.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). Stiffness was defined as a sensation of decreased ease of movement in study joint. The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the in the study joint during the past 48 hours. The WOMAC stiffness subscale score for each question ranges from 0 (minimum) to 4 (maximum), higher scores signifies worse stiffness. The stiffness subscale score ranges from 0 to 8, where higher scores indicated worse stiffness.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA of the hip and/or knee). The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 \[minimum\] to 4 \[maximum\], higher score indicating worse study joint condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
Adduction (external) moment was defined as the ground-generated torque that forces the distal tibia toward the midline of the body, which forces the knee away from the midline, into a varus or "bow-legged" position. External knee adduction moment was assessed as percent body weight\*height (%BW\*ht).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
Quadriceps inhibition was assessed in terms of flexion-extension range of motion and normalized mid stance knee flexion angle in degrees.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
Change from baseline in peak ground reaction force in body weight\*seconds (BW\*sec) was assessed with the help of a multicomponent force plate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
Change from baseline in total ground reaction force in body weight\*seconds was assessed with the help of a multicomponent force plate.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
The level walking was assessed by stride length; assessment was done based on 6 stride cycles over a range of walking speeds.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
Change from baseline in walking speed in meters per second was assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
Cadence was defined as the rate at which a person walk, expressed in steps per minute.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Week 12Population: As study was terminated, data for this outcome measure was not collected and analyzed due to low number of participant enrolled which were required to carry out the pre-specified efficacy analysis.
The PGAAC is self-administered measure in which participants answered the following question: "considering all the ways the OA in your signal knee affects you, how are you doing today?". Participants rated their condition using the following scale: 1= very good (no symptoms and no limitation of normal activities); 2= good (mild symptoms and no limitation of normal activities); 3= fair (moderate symptoms and limitation of some normal activities); 4= poor (severe symptoms and inability to carry out most normal activities); 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Celecoxib 100 mg
Oxycodone 20 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received placebo capsules matched to celecoxib and oxycodone orally, twice daily from Day 1 to 84 (Days 1-14 of treatment periods 1, 2, 3 and for 14 days prior to each of three treatment periods \[i.e. during 2-week washout period\])
|
Celecoxib 100 mg
n=6 participants at risk
Participants received celecoxib 100 mg (200 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period).
|
Oxycodone 20 mg
n=6 participants at risk
Participants received oxycodone controlled release 10 mg (20 mg/day) capsule orally, twice daily on Days 1-14 in each of three treatment periods (each 2-week treatment period was separated by a 2-week washout period).
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
50.0%
3/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Chills
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
50.0%
3/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
50.0%
3/6 • From signing of informed consent to 28 days after the last study drug administration (up to 17 months)
Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set population included all participants who received at least 1 dose of study medication.
|
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