Trial Outcomes & Findings for A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee (NCT NCT03028870)
NCT ID: NCT03028870
Last Updated: 2019-02-12
Results Overview
At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
291 participants
Primary outcome timeframe
Week 4
Results posted on
2019-02-12
Participant Flow
First subject first visit: 14-Mar-2017; last subject last visit: 21-Nov-2017. Thirty-one investigative centers in the United States participated in the study.
Participant milestones
| Measure |
V120083 30 mg
V120083 30 mg taken orally twice daily
|
V120083 60 mg
V120083 60 mg taken orally twice daily
|
Naproxen
Naproxen 500 mg taken orally twice daily
|
Placebo
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
74
|
67
|
76
|
74
|
|
Overall Study
COMPLETED
|
57
|
57
|
60
|
65
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
16
|
9
|
Reasons for withdrawal
| Measure |
V120083 30 mg
V120083 30 mg taken orally twice daily
|
V120083 60 mg
V120083 60 mg taken orally twice daily
|
Naproxen
Naproxen 500 mg taken orally twice daily
|
Placebo
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
0
|
0
|
|
Overall Study
Administrative
|
5
|
5
|
12
|
4
|
Baseline Characteristics
A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee
Baseline characteristics by cohort
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 8.66 • n=99 Participants
|
60.7 years
STANDARD_DEVIATION 8.62 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 8.94 • n=206 Participants
|
59.0 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 8.79 • n=31 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
183 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
108 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
214 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
70 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The full analysis population (FAP) (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
Baseline
|
5.9 score on a scale
Standard Error 0.20
|
5.9 score on a scale
Standard Error 0.18
|
6.1 score on a scale
Standard Error 0.16
|
5.9 score on a scale
Standard Error 0.21
|
|
Daily "Average Pain Over the Last 24 Hours" Score at Week 4
Week 4
|
4.2 score on a scale
Standard Error 0.28
|
4.3 score on a scale
Standard Error 0.28
|
3.6 score on a scale
Standard Error 0.26
|
4.4 score on a scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Weeks 1, 2 and 4Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
Baseline
|
6.242 score on a scale
Standard Error 0.1530
|
6.431 score on a scale
Standard Error 0.1408
|
6.469 score on a scale
Standard Error 0.1426
|
6.543 score on a scale
Standard Error 0.1497
|
|
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
Week 1 change from baseline
|
-0.920 score on a scale
Standard Error 0.1721
|
-0.860 score on a scale
Standard Error 0.1405
|
-1.655 score on a scale
Standard Error 0.1789
|
-0.977 score on a scale
Standard Error 0.1569
|
|
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
Week 2 change from baseline
|
-1.653 score on a scale
Standard Error 0.2087
|
-1.336 score on a scale
Standard Error 0.1998
|
-2.255 score on a scale
Standard Error 0.2443
|
-1.593 score on a scale
Standard Error 0.1979
|
|
Weekly Change From Baseline Score of "Average Pain Over the Last 24 Hours" From the mBPI-SF Pain Severity Subscale
Week 4 change from baseline
|
-1.959 score on a scale
Standard Error 0.2553
|
-1.803 score on a scale
Standard Error 0.2957
|
-2.741 score on a scale
Standard Error 0.2898
|
-1.952 score on a scale
Standard Error 0.2667
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Average Daily "Pain Right Now" Score Collected by e-Diary
Baseline
|
6.104 score on a scale
Standard Error 0.1851
|
6.737 score on a scale
Standard Error 0.2076
|
6.590 score on a scale
Standard Error 0.2223
|
6.481 score on a scale
Standard Error 0.2587
|
|
Average Daily "Pain Right Now" Score Collected by e-Diary
Week 4
|
6.366 score on a scale
Standard Error 0.6400
|
7.269 score on a scale
Standard Error 0.2627
|
6.000 score on a scale
Standard Error NA
Since only one subject reported a pain score, standard error was not calculated.
|
5.833 score on a scale
Standard Error 0.7318
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
Baseline
|
10.2 score on a scale
Standard Error 0.40
|
9.6 score on a scale
Standard Error 0.34
|
9.9 score on a scale
Standard Error 0.34
|
10.1 score on a scale
Standard Error 0.38
|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
Week 4
|
7.0 score on a scale
Standard Error 0.50
|
7.2 score on a scale
Standard Error 0.48
|
5.5 score on a scale
Standard Error 0.41
|
6.8 score on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
Baseline
|
4.6 score on a scale
Standard Error 0.17
|
4.5 score on a scale
Standard Error 0.18
|
4.2 score on a scale
Standard Error 0.17
|
4.5 score on a scale
Standard Error 0.17
|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
Week 4
|
3.2 score on a scale
Standard Error 0.20
|
3.3 score on a scale
Standard Error 0.24
|
2.6 score on a scale
Standard Error 0.19
|
3.1 score on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
Baseline
|
34.6 score on a scale
Standard Error 1.23
|
34.8 score on a scale
Standard Error 1.13
|
33.6 score on a scale
Standard Error 1.19
|
35.1 score on a scale
Standard Error 1.23
|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
Week 4
|
25.6 score on a scale
Standard Error 1.73
|
25.0 score on a scale
Standard Error 1.79
|
18.7 score on a scale
Standard Error 1.46
|
23.2 score on a scale
Standard Error 1.64
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
Baseline
|
49.3 score on a scale
Standard Error 1.67
|
48.9 score on a scale
Standard Error 1.54
|
47.6 score on a scale
Standard Error 1.55
|
49.6 score on a scale
Standard Error 1.65
|
|
Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
Week 4
|
35.8 score on a scale
Standard Error 2.35
|
35.5 score on a scale
Standard Error 2.45
|
26.8 score on a scale
Standard Error 1.99
|
33.1 score on a scale
Standard Error 2.25
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
Baseline
|
55.5 score on a scale
Standard Error 2.49
|
53.4 score on a scale
Standard Error 2.30
|
56.0 score on a scale
Standard Error 1.90
|
53.1 score on a scale
Standard Error 2.50
|
|
Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
Week 4
|
36.5 score on a scale
Standard Error 2.97
|
35.3 score on a scale
Standard Error 3.03
|
28.5 score on a scale
Standard Error 2.51
|
35.7 score on a scale
Standard Error 3.14
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
Baseline
|
5.784 score on a scale
Standard Error 0.2068
|
5.739 score on a scale
Standard Error 0.1935
|
5.747 score on a scale
Standard Error 0.1525
|
5.801 score on a scale
Standard Error 0.1978
|
|
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
Week 4
|
4.139 score on a scale
Standard Error 0.2840
|
4.135 score on a scale
Standard Error 0.2771
|
3.510 score on a scale
Standard Error 0.2543
|
4.308 score on a scale
Standard Error 0.2900
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
Baseline
|
4.618 score on a scale
Standard Error 0.2717
|
4.348 score on a scale
Standard Error 0.2573
|
4.718 score on a scale
Standard Error 0.2186
|
4.278 score on a scale
Standard Error 0.2721
|
|
Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
Week 4
|
2.847 score on a scale
Standard Error 0.2925
|
2.679 score on a scale
Standard Error 0.2961
|
2.070 score on a scale
Standard Error 0.2377
|
2.634 score on a scale
Standard Error 0.3049
|
SECONDARY outcome
Timeframe: Week 4Population: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
A subject's response to treatment was defined as the percentage reduction from the baseline "average pain over the last 24 hours" score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having \> 0 % reduction; non-responders were defined as having ≤ 0% reduction.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4
Responder - Yes
|
46 Participants
|
42 Participants
|
57 Participants
|
42 Participants
|
|
Responder to Treatment (Calculated as the Percentage Reduction of "Average Pain Over the Last 24 Hours") at Week 4
Responder - No
|
28 Participants
|
25 Participants
|
19 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
Baseline
|
31.689 score on a scale
Standard Error 0.9696
|
31.629 score on a scale
Standard Error 0.9146
|
32.348 score on a scale
Standard Error 1.0737
|
33.762 score on a scale
Standard Error 1.0315
|
|
Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
Week 4
|
35.515 score on a scale
Standard Error 1.3008
|
36.277 score on a scale
Standard Error 1.3584
|
39.372 score on a scale
Standard Error 1.2486
|
37.826 score on a scale
Standard Error 1.1440
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
Baseline
|
59.248 score on a scale
Standard Error 0.9688
|
59.766 score on a scale
Standard Error 1.1498
|
60.450 score on a scale
Standard Error 0.8714
|
59.450 score on a scale
Standard Error 1.0132
|
|
Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
Week 4
|
59.596 score on a scale
Standard Error 0.9615
|
59.560 score on a scale
Standard Error 1.0785
|
60.921 score on a scale
Standard Error 0.7819
|
60.948 score on a scale
Standard Error 0.8835
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 ("worst imaginable health state") to 100 ("best imaginable health state").
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
Baseline VAS Score
|
73.2 score on a scale
Standard Error 2.04
|
72.9 score on a scale
Standard Error 1.94
|
75.4 score on a scale
Standard Error 1.88
|
74.6 score on a scale
Standard Error 1.79
|
|
European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
Week 4 VAS Score
|
77.0 score on a scale
Standard Error 2.17
|
77.4 score on a scale
Standard Error 2.42
|
83.7 score on a scale
Standard Error 1.37
|
81.4 score on a scale
Standard Error 1.43
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding "very much improved" and "much improved" was summarized by treatment group.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC)
Total Subjects Completing PGIC
|
72 Participants
|
65 Participants
|
76 Participants
|
72 Participants
|
|
Patient Global Impression of Change (PGIC)
Subjects Responding 'Very Much' / 'Much' Improved
|
25 Participants
|
27 Participants
|
38 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.
The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.
Outcome measures
| Measure |
V120083 30 mg
n=38 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=35 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=34 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=40 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Supplemental Analgesic Medication Use
|
0.779 Supplemental Analgesic Tablets
Standard Error 0.1471
|
0.686 Supplemental Analgesic Tablets
Standard Error 0.1187
|
0.378 Supplemental Analgesic Tablets
Standard Error 0.0712
|
0.670 Supplemental Analgesic Tablets
Standard Error 0.1205
|
SECONDARY outcome
Timeframe: Baseline up to 4 WeeksPopulation: The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.
Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Suicidal ideation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Suicidal behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Suicidal ideation or behavior
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
Self-injurious behavior without suicidal intent
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.
Safety assessment to evaluate the impact of V120083 on mood (anxiety \[HADS-A\] and depression \[HADS-D\]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.
Outcome measures
| Measure |
V120083 30 mg
n=74 Participants
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 Participants
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 Participants
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 Participants
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
Week 4 change from baseline - HADS-D
|
0.3 score on a scale
Standard Error 0.25
|
0.6 score on a scale
Standard Error 0.31
|
-0.2 score on a scale
Standard Error 0.29
|
-0.1 score on a scale
Standard Error 0.30
|
|
Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
Week 4 change from baseline - HADS-A
|
-0.5 score on a scale
Standard Error 0.26
|
-0.3 score on a scale
Standard Error 0.26
|
-0.4 score on a scale
Standard Error 0.30
|
-0.6 score on a scale
Standard Error 0.35
|
Adverse Events
V120083 30 mg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
V120083 60 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Naproxen
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
V120083 30 mg
n=74 participants at risk
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 participants at risk
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 participants at risk
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 participants at risk
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
1.5%
1/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
1.5%
1/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Investigations
Transaminases increased
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
1.5%
1/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Psychiatric disorders
Delerium tremens
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
1.3%
1/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
Other adverse events
| Measure |
V120083 30 mg
n=74 participants at risk
V120083 30 mg taken orally twice daily
|
V120083 60 mg
n=67 participants at risk
V120083 60 mg taken orally twice daily
|
Naproxen
n=76 participants at risk
Naproxen 500 mg taken orally twice daily
|
Placebo
n=74 participants at risk
To match V120083 and/or naproxen taken orally twice daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.8%
5/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
7.5%
5/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
11.8%
9/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
5.4%
4/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
6.6%
5/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.4%
4/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
9.0%
6/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
5.4%
4/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
7.5%
5/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
0.00%
0/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
|
Nervous system disorders
Dysgeusia
|
17.6%
13/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
19.4%
13/67 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
9.2%
7/76 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
10.8%
8/74 • Adverse events (AEs) were reported from the start of study participation up to 5 weeks and from the start of study participation up to 30 days after last study drug dose for serious AEs.
AEs were learned of through spontaneous reports and/or subject interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or for 30 days after last study drug dose. Serious AEs reported within 30 days after the subject's last study drug dose or through the last study visit (whichever was later), were followed until the event resolved or sequelae stabilized.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60