Trial Outcomes & Findings for Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis (NCT NCT00664560)
NCT ID: NCT00664560
Last Updated: 2012-02-27
Results Overview
Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
COMPLETED
PHASE3
614 participants
Baseline and 12 weeks
2012-02-27
Participant Flow
Participant milestones
| Measure |
(PN 400 (VIMOVO) Twice Daily)
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Overall Study
STARTED
|
247
|
243
|
124
|
|
Overall Study
COMPLETED
|
208
|
208
|
105
|
|
Overall Study
NOT COMPLETED
|
39
|
35
|
19
|
Reasons for withdrawal
| Measure |
(PN 400 (VIMOVO) Twice Daily)
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
19
|
16
|
7
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
|
Overall Study
Other
|
11
|
4
|
5
|
Baseline Characteristics
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
Baseline characteristics by cohort
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=247 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=243 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 Participants
placebo (sugar pill) dosed twice daily (bid)
|
Total
n=614 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
62.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
61.9 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
222 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Analysis Population: Baseline + took \>= 1 dose + \>= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward
Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=226 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=221 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=108 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline
|
-43.4 mm
Standard Deviation 26.8
|
-41.1 mm
Standard Deviation 26.2
|
-34.0 mm
Standard Deviation 25.3
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analysis Population: Baseline + took \>= 1 dose + \>= 1 post-baseline WOMAC efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward
WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm). The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=226 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=221 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=108 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline
|
-37.5 mm
Standard Deviation 27.1
|
-36.0 mm
Standard Deviation 26.4
|
-28.9 mm
Standard Deviation 24.9
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analysis Population: Baseline + took \>= 1 dose + \>= 1 post-baseline PGA efficacy evaluation (intent-to-treat population). Used Last Observation Carried Forward
PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=242 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=230 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=119 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Change in Patient Global Assessment (PGA) Subscore From Baseline
|
21.5 mm
Standard Deviation 33.4
|
22.4 mm
Standard Deviation 28.7
|
12.4 mm
Standard Deviation 28.9
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: Intent to Treat
Mean change from Baseline scores calculated for each subject through Day 7. Scale 0 through 70, where 0=no pain interference and 70=complete interference.
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=246 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=242 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
American Pain Society Patient Outcome Questionnaire (APS-POQ)Total Interference Caused by Pain.
|
-17.8 Units on a scale
Standard Deviation 14.3
|
-17.7 Units on a scale
Standard Deviation 16.0
|
-12.8 Units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Week 6Population: Intent to treat
Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 6 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=198 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=187 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=101 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Change in Western Ontario and McMaster Universities (WOMAC) Pain Questionnaire Subscore From Baseline
|
-40.9 mm
Standard Deviation 26.9
|
-39.4 mm
Standard Deviation 25.4
|
-30.7 mm
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: Week 6Population: Intent to treat
WOMAC function questionnaire (VAS). The 17 questions about function all use visual analog scale (VAS) of 100 mm; 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain from baseline (in mm). The Western Ontario and McMaster Universities (WOMAC) is a self-administered, patient-reported health status questionnaire that is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function).
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=198 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=187 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=101 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Change in Western Ontario and McMaster Universities (WOMAC) Function Questionnaire Subscore From Baseline
|
-35.3 mm
Standard Deviation 26.9
|
-33.9 mm
Standard Deviation 25.6
|
-27.3 mm
Standard Deviation 26
|
SECONDARY outcome
Timeframe: Week 6Population: Intent to treat
PGA questionnaire. The patient global assessment (PGA) question asks about how the subject is doing considering his/her arthritis and is measured by a visual analog scale (VAS); 0 mm (very poor) 100 mm (excellent). The outcome measures a change from baseline PGA in mm.
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=239 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=227 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=119 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Change in Patient Global Assessment (PGA) Subscore From Baseline
|
22.6 mm
Standard Deviation 31.6
|
20.7 mm
Standard Deviation 28.8
|
14.7 mm
Standard Deviation 29.3
|
SECONDARY outcome
Timeframe: 12 weeksTablet pill count
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=246 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=242 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Antacid Tablet Use
|
9.3 Tablets per subject
Standard Deviation 17.5
|
13.9 Tablets per subject
Standard Deviation 21.6
|
15.4 Tablets per subject
Standard Deviation 37.6
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from Baseline in the Modified Severity of Dyspepsia Assessment (mSODA) average daily pain intensity converted total score at Week 12. The mSODA instruments consists of 6 questions about abdominal discomfort during the past 24 hours, with a converted score of 2 through 47. Lower score equals less pain.
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=245 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=237 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=123 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Modified Severity of Dyspepsia Assessment (mSODA)
|
-3.5 Scores on a scale
Standard Deviation 9.3
|
-4.8 Scores on a scale
Standard Deviation 9.1
|
-4.0 Scores on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat
During 12 weeks, daily heartburn question with ratings none, mild, moderate, or severe. Percent of days with Heartburn resolution (heartburn is none).
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=245 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=241 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=123 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Percent of Days With no Heartburn (Heartburn Resolution)
|
83.9 percent days
Standard Deviation 29.8
|
75.8 percent days
Standard Deviation 34.1
|
68.5 percent days
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: daily during 12 weeksPopulation: Safety population
Number of participants reporting pre-specified non-steroidal antiinflammatory drug-associated (NSAID) upper gastrointestinal (UGI) symptoms. Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=247 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=243 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Number of Participants Reporting Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal (UGI) Symptoms
|
41 participants
|
41 participants
|
24 participants
|
SECONDARY outcome
Timeframe: daily during 12 weeksPopulation: Safety population
The number of subjects who discontinued from the study due to any pre-specified non-steroidal antiinflammatory drug (NSAID)-associated upper gastrointestinal (UGI) adverse event (as classified by MedDRA). Pre-specified NSAID-associated UGI symptoms include adverse events such as dyspepsia, abdominal pain or discomfort, nausea, vomiting.
Outcome measures
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=247 Participants
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=243 Participants
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 Participants
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
The Number of Subjects Who Discontinued From the Study Due to Any Pre-specified Non-steroidal Antiinflammatory Drug-associated Upper Gastrointestinal Adverse Event
|
3 participants
|
4 participants
|
3 participants
|
Adverse Events
(PN 400 (VIMOVO) Twice Daily)
(Celebrex 200 mg Once Daily)
(Placebo Twice Daily)
Serious adverse events
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=247 participants at risk
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=243 participants at risk
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 participants at risk
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/243 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
pancreatitis acute
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/243 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Injury, poisoning and procedural complications
incisional hernia
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/243 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.00%
0/247 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/243 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Psychiatric disorders
Cerebrovascular accident
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/243 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/247 • randomization -28 days post last dose
|
0.82%
2/243 • Number of events 2 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
General disorders
Swelling
|
0.00%
0/247 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/247 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
|
Infections and infestations
Gangrene
|
0.00%
0/247 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
0.00%
0/124 • randomization -28 days post last dose
|
Other adverse events
| Measure |
(PN 400 (VIMOVO) Twice Daily)
n=247 participants at risk
PN 400 (VIMOVO): 500 mg naproxen/20 mg esomeprazole
|
(Celebrex 200 mg Once Daily)
n=243 participants at risk
Celecoxib 200 mg (Celebrex) taken once daily
|
(Placebo Twice Daily)
n=124 participants at risk
placebo (sugar pill) dosed twice daily (bid)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
15/247 • Number of events 15 • randomization -28 days post last dose
|
3.3%
8/243 • Number of events 8 • randomization -28 days post last dose
|
2.4%
3/124 • Number of events 3 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
13/247 • Number of events 13 • randomization -28 days post last dose
|
7.8%
19/243 • Number of events 19 • randomization -28 days post last dose
|
11.3%
14/124 • Number of events 14 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Nausea
|
4.9%
12/247 • Number of events 12 • randomization -28 days post last dose
|
2.5%
6/243 • Number of events 6 • randomization -28 days post last dose
|
4.8%
6/124 • Number of events 6 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
10/247 • Number of events 10 • randomization -28 days post last dose
|
3.7%
9/243 • Number of events 9 • randomization -28 days post last dose
|
1.6%
2/124 • Number of events 2 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Constipation
|
3.6%
9/247 • Number of events 9 • randomization -28 days post last dose
|
2.1%
5/243 • Number of events 5 • randomization -28 days post last dose
|
1.6%
2/124 • Number of events 2 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
5/247 • Number of events 5 • randomization -28 days post last dose
|
0.82%
2/243 • Number of events 2 • randomization -28 days post last dose
|
3.2%
4/124 • Number of events 4 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
4/247 • Number of events 4 • randomization -28 days post last dose
|
2.5%
6/243 • Number of events 6 • randomization -28 days post last dose
|
1.6%
2/124 • Number of events 2 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.2%
3/247 • Number of events 3 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
2.4%
3/124 • Number of events 3 • randomization -28 days post last dose
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
2.5%
6/243 • Number of events 6 • randomization -28 days post last dose
|
0.81%
1/124 • Number of events 1 • randomization -28 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
5/247 • Number of events 5 • randomization -28 days post last dose
|
2.1%
5/243 • Number of events 5 • randomization -28 days post last dose
|
2.4%
3/124 • Number of events 3 • randomization -28 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
2/247 • Number of events 2 • randomization -28 days post last dose
|
2.1%
5/243 • Number of events 5 • randomization -28 days post last dose
|
3.2%
4/124 • Number of events 4 • randomization -28 days post last dose
|
|
Infections and infestations
Sinusitis
|
2.0%
5/247 • Number of events 5 • randomization -28 days post last dose
|
1.2%
3/243 • Number of events 3 • randomization -28 days post last dose
|
3.2%
4/124 • Number of events 4 • randomization -28 days post last dose
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
3/247 • Number of events 3 • randomization -28 days post last dose
|
1.2%
3/243 • Number of events 3 • randomization -28 days post last dose
|
4.0%
5/124 • Number of events 5 • randomization -28 days post last dose
|
|
Infections and infestations
Gastroenteritis viral
|
0.81%
2/247 • Number of events 2 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
2.4%
3/124 • Number of events 3 • randomization -28 days post last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
0.40%
1/247 • Number of events 1 • randomization -28 days post last dose
|
1.6%
4/243 • Number of events 4 • randomization -28 days post last dose
|
2.4%
3/124 • Number of events 3 • randomization -28 days post last dose
|
|
Nervous system disorders
Dizziness
|
2.8%
7/247 • Number of events 7 • randomization -28 days post last dose
|
0.82%
2/243 • Number of events 2 • randomization -28 days post last dose
|
3.2%
4/124 • Number of events 4 • randomization -28 days post last dose
|
|
Nervous system disorders
Headache
|
2.8%
7/247 • Number of events 7 • randomization -28 days post last dose
|
4.1%
10/243 • Number of events 10 • randomization -28 days post last dose
|
4.0%
5/124 • Number of events 5 • randomization -28 days post last dose
|
|
General disorders
Oedema peripheral
|
3.6%
9/247 • Number of events 9 • randomization -28 days post last dose
|
1.2%
3/243 • Number of events 3 • randomization -28 days post last dose
|
0.81%
1/124 • Number of events 1 • randomization -28 days post last dose
|
|
General disorders
Fatigue
|
1.2%
3/247 • Number of events 3 • randomization -28 days post last dose
|
0.82%
2/243 • Number of events 2 • randomization -28 days post last dose
|
2.4%
3/124 • Number of events 3 • randomization -28 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.81%
2/247 • Number of events 2 • randomization -28 days post last dose
|
0.41%
1/243 • Number of events 1 • randomization -28 days post last dose
|
4.0%
5/124 • Number of events 5 • randomization -28 days post last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place