Trial Outcomes & Findings for Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) (NCT NCT00322621)
NCT ID: NCT00322621
Last Updated: 2011-02-07
Results Overview
Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
216 participants
Primary outcome timeframe
Baseline (Week 8), Week 34
Results posted on
2011-02-07
Participant Flow
Study Period I was a 5-9 day Screening Phase. Study Period II was an 8 week Acute Therapy Phase. Study Period III was a 26 week Maintenance and Rescue Therapy Phase. Study Period IV was a 2 week Taper Phase.
Participant milestones
| Measure |
Acute Phase
All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
|
Maintenance Arm
Duloxetine: 60 milligrams once daily.
|
Rescue Arm
Duloxetine: 120 milligrams once daily.
|
|---|---|---|---|
|
Period II - Acute Therapy Phase
STARTED
|
216
|
0
|
0
|
|
Period II - Acute Therapy Phase
COMPLETED
|
184
|
0
|
0
|
|
Period II - Acute Therapy Phase
NOT COMPLETED
|
32
|
0
|
0
|
|
Period III - Maintenance / Rescue Phase
STARTED
|
0
|
115
|
69
|
|
Period III - Maintenance / Rescue Phase
COMPLETED
|
0
|
86
|
33
|
|
Period III - Maintenance / Rescue Phase
NOT COMPLETED
|
0
|
29
|
36
|
Reasons for withdrawal
| Measure |
Acute Phase
All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
|
Maintenance Arm
Duloxetine: 60 milligrams once daily.
|
Rescue Arm
Duloxetine: 120 milligrams once daily.
|
|---|---|---|---|
|
Period II - Acute Therapy Phase
Adverse Event
|
20
|
0
|
0
|
|
Period II - Acute Therapy Phase
Lack of Efficacy
|
1
|
0
|
0
|
|
Period II - Acute Therapy Phase
Withdrawal by Subject
|
8
|
0
|
0
|
|
Period II - Acute Therapy Phase
Protocol Violation
|
2
|
0
|
0
|
|
Period II - Acute Therapy Phase
Physician Decision
|
1
|
0
|
0
|
|
Period III - Maintenance / Rescue Phase
Adverse Event
|
0
|
14
|
5
|
|
Period III - Maintenance / Rescue Phase
Lack of Efficacy
|
0
|
4
|
24
|
|
Period III - Maintenance / Rescue Phase
Withdrawal by Subject
|
0
|
7
|
1
|
|
Period III - Maintenance / Rescue Phase
Protocol Violation
|
0
|
2
|
5
|
|
Period III - Maintenance / Rescue Phase
Death
|
0
|
1
|
0
|
|
Period III - Maintenance / Rescue Phase
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Maintenance of Effect of Duloxetine in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Baseline characteristics by cohort
| Measure |
Acute Phase
n=216 Participants
All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
|
|---|---|
|
Age Continuous
|
63.3 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
41 participants
n=5 Participants
|
|
Duration of Diabetes
<=2 years
|
78 participants
n=5 Participants
|
|
Duration of Diabetes
>2 years
|
138 participants
n=5 Participants
|
|
Duration of Neuropathic Pain
<=1 year
|
38 participants
n=5 Participants
|
|
Duration of Neuropathic Pain
>1 year
|
178 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
173 participants
n=5 Participants
|
|
Race/Ethnicity
West Asian
|
33 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
6 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
4 participants
n=5 Participants
|
|
Type of Diabetes Mellitus
Type 1
|
12 participants
n=5 Participants
|
|
Type of Diabetes Mellitus
Type 2
|
204 participants
n=5 Participants
|
|
Brief Pain Inventory 24-Hour Average Pain Severity
|
5.88 units on a scale
STANDARD_DEVIATION 1.45 • n=5 Participants
|
|
Height at Visit 1 (Week -1)
|
166.7 centimeters (cm)
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Weight at Visit 2 (Week 0)
|
84.0 kilograms (kg)
STANDARD_DEVIATION 18.36 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Patients entering maintenance phase on duloxetine 60 mg QD. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
|
0.35 units on a scale
Standard Deviation 2.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
|
76 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=66 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item
|
21 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
|
0.29 units on a scale
Standard Deviation 2.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=67 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint
|
-1.33 units on a scale
Standard Deviation 2.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
|
0.24 units on a scale
Standard Deviation 1.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=67 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint
|
-0.93 units on a scale
Standard Deviation 3.07
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint
|
0.35 units on a scale
Standard Deviation 2.09
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=66 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint
|
-1.39 units on a scale
Standard Deviation 2.57
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
|
0.48 units on a scale
Standard Deviation 2.28
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Outcome measures
| Measure |
Maintenance Arm
n=67 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint
|
-1.12 units on a scale
Standard Deviation 3.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
|
0.22 units on a scale
Standard Deviation 2.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint
|
-1.01 units on a scale
Standard Deviation 3.53
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
|
0.39 units on a scale
Standard Deviation 2.63
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint
|
-0.29 units on a scale
Standard Deviation 3.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint
|
0.59 units on a scale
Standard Deviation 3.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint
|
-1.15 units on a scale
Standard Deviation 3.49
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
|
0.63 units on a scale
Standard Deviation 2.72
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=67 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint
|
-0.97 units on a scale
Standard Deviation 3.40
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
|
0.13 units on a scale
Standard Deviation 2.22
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=67 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint
|
-0.12 units on a scale
Standard Deviation 3.08
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
|
-0.10 units on a scale
Standard Deviation 2.83
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint
|
-0.84 units on a scale
Standard Deviation 3.69
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
|
0.11 units on a scale
Standard Deviation 3.06
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint
|
0.19 units on a scale
Standard Deviation 3.79
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=111 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
|
0.28 units on a scale
Standard Deviation 2.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint
|
-0.59 units on a scale
Standard Deviation 3.04
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 34Population: Number of responders with at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
|
2.32 units on a scale
Standard Deviation 1.33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint
|
3.04 units on a scale
Standard Deviation 1.32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Maintenance Arm
n=114 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
|
-0.11 units on a scale
Standard Deviation 1.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint
|
-0.46 units on a scale
Standard Deviation 1.23
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and ate least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Maintenance Arm
n=108 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
|
0.31 units on a scale
Standard Deviation 7.34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
This instrument consists of 11 pain descriptors. The sensory pain portion scores range from 0 (none) to 3 (severe).
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint
|
-1.38 units on a scale
Standard Deviation 7.60
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Maintenance Arm
n=109 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
|
-0.82 units on a scale
Standard Deviation 5.80
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8), Week 34Population: Number of non-responders with a baseline and at least one non-missing post-baseline score. Endpoint is the last non-missing measure from Week 12 to Week 34. Last observation carried forward.
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Outcome measures
| Measure |
Maintenance Arm
n=68 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint
|
-0.53 units on a scale
Standard Deviation 6.62
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 8Population: Participants in Acute Phase (through Week 8).
Outcome measures
| Measure |
Maintenance Arm
n=216 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Number of Participants Discontinuing in the Acute Phase
Initiating at Week 0
|
216 participants
|
—
|
—
|
—
|
|
Number of Participants Discontinuing in the Acute Phase
Continuing at Week 1
|
201 participants
|
—
|
—
|
—
|
|
Number of Participants Discontinuing in the Acute Phase
Continuing at Week 8
|
184 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 8) to Week 34Population: Participants in Maintenance / Rescue Phase (beyond Week 8 through Week 34)
Outcome measures
| Measure |
Maintenance Arm
n=184 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
n=103 Participants
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
n=12 Participants
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
n=69 Participants
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Number of Participants Discontinuing in Maintenance / Rescue Phase
Entering at Week 8
|
184 participants
|
103 participants
|
12 participants
|
69 participants
|
|
Number of Participants Discontinuing in Maintenance / Rescue Phase
Continuing at Week 12
|
171 participants
|
96 participants
|
12 participants
|
63 participants
|
|
Number of Participants Discontinuing in Maintenance / Rescue Phase
Continuing at Week 16
|
142 participants
|
92 participants
|
11 participants
|
39 participants
|
|
Number of Participants Discontinuing in Maintenance / Rescue Phase
Continuing at Week 24
|
128 participants
|
84 participants
|
10 participants
|
34 participants
|
|
Number of Participants Discontinuing in Maintenance / Rescue Phase
Completing at Week 34
|
119 participants
|
77 participants
|
9 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 34Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
Outcome measures
| Measure |
Maintenance Arm
n=214 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
n=80 Participants
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint
|
2.4 beats per minute
Standard Deviation 10.78
|
0.4 beats per minute
Standard Deviation 11.46
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 34Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
Outcome measures
| Measure |
Maintenance Arm
n=214 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
n=80 Participants
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint
|
-0.1 mm Hg
Standard Deviation 9.39
|
-1.0 mm Hg
Standard Deviation 9.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 34Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
Outcome measures
| Measure |
Maintenance Arm
n=214 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
n=80 Participants
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint
|
-4.2 mm Hg
Standard Deviation 14.94
|
0.7 mm Hg
Standard Deviation 15.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 34Population: All patients who received either 60 mg or 120 mg duloxetine once daily.
Outcome measures
| Measure |
Maintenance Arm
n=214 Participants
Duloxetine: 60 milligrams once daily
|
Maintenance Arm (No Dose Increase)
n=80 Participants
duloxetine 60 mg once daily
|
Maintenance Arm (Later Dose Increase)
duloxetine 60 mg once daily and then increasing to 120 mg once daily
|
Rescue Arm
duloxetine 120 mg once daily
|
|---|---|---|---|---|
|
Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint
|
-1.3 kilograms (kg)
Standard Deviation 4.17
|
0.2 kilograms (kg)
Standard Deviation 3.16
|
—
|
—
|
Adverse Events
Duloxetine 60 mg
Serious events: 18 serious events
Other events: 135 other events
Deaths: 0 deaths
Duloxetine 120 mg
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Duloxetine 60 mg
n=216 participants at risk
Duloxetine: 60 milligrams once daily
|
Duloxetine 120 mg
n=81 participants at risk
Duloxetine: 120 milligrams once daily
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Endocrine disorders
Hyperthyroidism
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Eye disorders
Cataract
|
0.93%
2/216 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
General disorders
Chest pain
|
0.93%
2/216 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
General disorders
Sudden death
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/216 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Nervous system disorders
Syncope
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/216 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Renal and urinary disorders
Anuria
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Renal and urinary disorders
Urinary retention
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
Other adverse events
| Measure |
Duloxetine 60 mg
n=216 participants at risk
Duloxetine: 60 milligrams once daily
|
Duloxetine 120 mg
n=81 participants at risk
Duloxetine: 120 milligrams once daily
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
9/216 • Number of events 9 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
5/216 • Number of events 7 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
4.9%
4/81 • Number of events 4 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
9/216 • Number of events 9 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
7/216 • Number of events 9 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
8.6%
7/81 • Number of events 9 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
13/216 • Number of events 13 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
41/216 • Number of events 46 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
3.7%
3/81 • Number of events 3 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
7/216 • Number of events 7 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
General disorders
Asthenia
|
5.1%
11/216 • Number of events 12 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
General disorders
Chills
|
3.2%
7/216 • Number of events 8 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
General disorders
Fatigue
|
5.1%
11/216 • Number of events 18 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Infections and infestations
Influenza
|
2.3%
5/216 • Number of events 5 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
5/216 • Number of events 5 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/216 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
12/216 • Number of events 12 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
6/216 • Number of events 7 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
3/216 • Number of events 4 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
8/216 • Number of events 9 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.8%
6/216 • Number of events 15 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
7/216 • Number of events 12 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Nervous system disorders
Dizziness
|
3.2%
7/216 • Number of events 9 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Nervous system disorders
Headache
|
5.1%
11/216 • Number of events 24 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
3.7%
3/81 • Number of events 3 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Nervous system disorders
Somnolence
|
8.3%
18/216 • Number of events 19 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
3.7%
3/81 • Number of events 3 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Psychiatric disorders
Insomnia
|
2.8%
6/216 • Number of events 6 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 3 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.2%
7/216 • Number of events 7 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
0.00%
0/81 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
14/216 • Number of events 16 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
1.2%
1/81 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Vascular disorders
Arteriosclerosis
|
0.46%
1/216 • Number of events 1 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
|
Vascular disorders
Hypertension
|
1.9%
4/216 • Number of events 4 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
2.5%
2/81 • Number of events 2 • 34 Weeks
There were 12 patients who began the maintenance dose group who had their dose increased to rescue dose of 120 mg QD at some point during the maintenance period. Adverse events reported were attributed to the dose the participant was on at the time of the event, therefore, the 12 participants were also included in the 120 mg QD group.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60