Trial Outcomes & Findings for Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder (NCT NCT00810069)
NCT ID: NCT00810069
Last Updated: 2011-06-21
Results Overview
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
840 participants
Primary outcome timeframe
Week 4 through Week 16
Results posted on
2011-06-21
Participant Flow
Participants showing improvement (≥30% baseline score reduction on the HAMD-17) during Period I did not continue to Period II of the study. Qualified participants for Period II were randomized to either Early Intervention Strategy Arm or Delayed Intervention Strategy Arm.
Baseline demographics and primary and secondary outcomes are reported only for Period II (Double Blind Treatment Strategy). Adverse events (AEs) are reported for Period I (Acute Escitalopram Treatment) and Period II.
Participant milestones
| Measure |
Escitalopram (Acute Treatment)
Escitalopram 10 milligrams (mg) per day for 4 weeks
|
Early Intervention
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|---|
|
Lead-in Period I
STARTED
|
840
|
0
|
0
|
|
Lead-in Period I
COMPLETED
|
566
|
0
|
0
|
|
Lead-in Period I
NOT COMPLETED
|
274
|
0
|
0
|
|
Double-Blind Period II
STARTED
|
0
|
282
|
284
|
|
Double-Blind Period II
COMPLETED
|
0
|
226
|
212
|
|
Double-Blind Period II
NOT COMPLETED
|
0
|
56
|
72
|
Reasons for withdrawal
| Measure |
Escitalopram (Acute Treatment)
Escitalopram 10 milligrams (mg) per day for 4 weeks
|
Early Intervention
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|---|
|
Lead-in Period I
Adverse Event
|
43
|
0
|
0
|
|
Lead-in Period I
Lack of Efficacy
|
1
|
0
|
0
|
|
Lead-in Period I
Lost to Follow-up
|
19
|
0
|
0
|
|
Lead-in Period I
Physician Decision
|
1
|
0
|
0
|
|
Lead-in Period I
Protocol Violation
|
1
|
0
|
0
|
|
Lead-in Period I
Withdrawal by Subject
|
46
|
0
|
0
|
|
Lead-in Period I
Protocol entry criterion not met
|
5
|
0
|
0
|
|
Lead-in Period I
Randomization criteria not met
|
158
|
0
|
0
|
|
Double-Blind Period II
Adverse Event
|
0
|
9
|
8
|
|
Double-Blind Period II
Lack of Efficacy
|
0
|
7
|
12
|
|
Double-Blind Period II
Lost to Follow-up
|
0
|
9
|
9
|
|
Double-Blind Period II
Physician Decision
|
0
|
0
|
1
|
|
Double-Blind Period II
Withdrawal by Subject
|
0
|
21
|
35
|
|
Double-Blind Period II
Protocol entry criterion not met
|
0
|
0
|
1
|
|
Double-Blind Period II
Clinical relapse
|
0
|
3
|
0
|
|
Double-Blind Period II
Protocol Violation
|
0
|
7
|
6
|
Baseline Characteristics
Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
Total
n=566 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.3 years
STANDARD_DEVIATION 13.48 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
47.9 years
STANDARD_DEVIATION 13.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
54 participants
n=5 Participants
|
54 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
71 participants
n=5 Participants
|
73 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
71 participants
n=5 Participants
|
71 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Race
Black or African American
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race
White
|
280 participants
n=5 Participants
|
282 participants
n=7 Participants
|
562 participants
n=5 Participants
|
|
Clinical Global Impression-Major Depressive Disorder-Severity (CGI-MDD-S) Score
|
4.6 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
|
Quick Inventory of Depressive Symptomatology-Self Reported (QIDS16SR) Total Score
|
16.4 units on a scale
STANDARD_DEVIATION 3.82 • n=5 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 3.43 • n=7 Participants
|
16.5 units on a scale
STANDARD_DEVIATION 3.63 • n=5 Participants
|
|
17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
|
24.0 units on a scale
STANDARD_DEVIATION 3.57 • n=5 Participants
|
24.4 units on a scale
STANDARD_DEVIATION 3.83 • n=7 Participants
|
24.2 units on a scale
STANDARD_DEVIATION 3.70 • n=5 Participants
|
|
Visual Analog Scale (VAS) Overall Pain Severity
|
3.6 units on a scale
STANDARD_DEVIATION 2.76 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 2.81 • n=7 Participants
|
3.7 units on a scale
STANDARD_DEVIATION 2.78 • n=5 Participants
|
|
Sheehan Disability Scale (SDS) Total Score
|
19.9 units on a scale
STANDARD_DEVIATION 5.12 • n=5 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 5.52 • n=7 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 5.32 • n=5 Participants
|
|
Euro Quality of Life-5 Dimensions Questionnaire (EQ-5D) Score
EQ-5D UK Population-based Index Score
|
0.40 units on a scale
STANDARD_DEVIATION 0.291 • n=5 Participants
|
0.34 units on a scale
STANDARD_DEVIATION 0.312 • n=7 Participants
|
0.37 units on a scale
STANDARD_DEVIATION 0.303 • n=5 Participants
|
|
Euro Quality of Life-5 Dimensions Questionnaire (EQ-5D) Score
Health State Score
|
4.23 units on a scale
STANDARD_DEVIATION 1.873 • n=5 Participants
|
3.86 units on a scale
STANDARD_DEVIATION 1.704 • n=7 Participants
|
4.05 units on a scale
STANDARD_DEVIATION 1.798 • n=5 Participants
|
|
Number of work hours worked per week
|
38.0 hours
STANDARD_DEVIATION 8.30 • n=5 Participants
|
37.2 hours
STANDARD_DEVIATION 9.53 • n=7 Participants
|
37.6 hours
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Number of work hours missed in the last 4 weeks
|
86.9 hours
STANDARD_DEVIATION 63.09 • n=5 Participants
|
87.5 hours
STANDARD_DEVIATION 66.32 • n=7 Participants
|
87.2 hours
STANDARD_DEVIATION 64.67 • n=5 Participants
|
|
Number of work hours missed due to depression in the last 4 weeks
|
88.8 hours
STANDARD_DEVIATION 64.14 • n=5 Participants
|
88.5 hours
STANDARD_DEVIATION 67.05 • n=7 Participants
|
88.6 hours
STANDARD_DEVIATION 65.56 • n=5 Participants
|
|
Number of visits to primary healthcare provider due to depression in the last 4 weeks
|
1.6 visits
STANDARD_DEVIATION 0.95 • n=5 Participants
|
1.8 visits
STANDARD_DEVIATION 1.10 • n=7 Participants
|
1.7 visits
STANDARD_DEVIATION 1.03 • n=5 Participants
|
|
Number of visits to emergency room or equivalent facility due to depression in the last 4 weeks
|
1.1 visits
STANDARD_DEVIATION 0.27 • n=5 Participants
|
1.1 visits
STANDARD_DEVIATION 0.48 • n=7 Participants
|
1.1 visits
STANDARD_DEVIATION 0.40 • n=5 Participants
|
|
Number of visits to other specialists due to depression in the last 4 weeks
|
2.0 visits
STANDARD_DEVIATION 1.44 • n=5 Participants
|
1.6 visits
STANDARD_DEVIATION 0.98 • n=7 Participants
|
1.8 visits
STANDARD_DEVIATION 1.26 • n=5 Participants
|
|
Has the participant been hospitalized due to depression in the last 4 weeks
Yes
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Has the participant been hospitalized due to depression in the last 4 weeks
No
|
277 participants
n=5 Participants
|
278 participants
n=7 Participants
|
555 participants
n=5 Participants
|
|
Has the participant been hospitalized due to depression in the last 4 weeks
Unknown
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Has the participant been hospitalized due to depression in the last 4 weeks
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4 through Week 16Population: Full Analysis Set
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
|
6.4 weeks
Interval 6.0 to 8.0
|
8.0 weeks
Interval 6.4 to 8.6
|
PRIMARY outcome
Timeframe: Week 4 through Week 16Population: Full Analysis Population
Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as \>=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
|
28 estimated probability (percent)
Interval 22.0 to 34.0
|
26 estimated probability (percent)
Interval 20.0 to 32.0
|
PRIMARY outcome
Timeframe: Week 4 through Week 16Population: Full Analysis Population
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
|
12.9 weeks
Interval 11.0 to
No maximum value was reported for the 95% confidence interval. It was not reported as it could not be estimated due to the low number of events.
|
NA weeks
Interval 12.3 to
50% remission (median) could not be estimated for delayed intervention arm due to the low number of events.
|
PRIMARY outcome
Timeframe: Week 4 through Week 16Population: Full Analysis Population
Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
|
52 estimated probability (percent)
Interval 46.0 to 58.0
|
59 estimated probability (percent)
Interval 53.0 to 66.0
|
SECONDARY outcome
Timeframe: Week 4 through Week 16Population: Full Analysis Population
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits
|
6.0 weeks
Interval 5.0 to 8.0
|
6.9 weeks
Interval 5.3 to 8.0
|
SECONDARY outcome
Timeframe: Week 4 through Week 16Population: Full Analysis Population
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Outcome measures
| Measure |
Early Intervention
n=280 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.
|
NA weeks
Interval 12.3 to
It could not be estimated due to the low number of events.
|
NA weeks
Interval 12.3 to
It could not be estimated due to the low number of events.
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16Population: Full Analysis Population
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 participants).
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Baseline (n=282, 284)
|
4.6 units on a scale
Standard Deviation 0.59
|
4.6 units on a scale
Standard Deviation 0.64
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 4 (n=281, 284)
|
4.3 units on a scale
Standard Deviation 0.61
|
4.3 units on a scale
Standard Deviation 0.66
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 6 (n=271, 277)
|
3.6 units on a scale
Standard Deviation 0.88
|
3.7 units on a scale
Standard Deviation 0.97
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 8 (n=254, 254)
|
3.2 units on a scale
Standard Deviation 1.11
|
3.3 units on a scale
Standard Deviation 1.15
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 10 (n=231, 236)
|
2.8 units on a scale
Standard Deviation 1.17
|
2.9 units on a scale
Standard Deviation 1.22
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 12 (n=203, 214)
|
2.6 units on a scale
Standard Deviation 1.21
|
2.7 units on a scale
Standard Deviation 1.20
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 14 (n=184, 194)
|
2.4 units on a scale
Standard Deviation 1.13
|
2.5 units on a scale
Standard Deviation 1.17
|
|
Clinical Global Impressions of Severity (CGI-S) Scale
Week 16 (n=178, 182)
|
2.2 units on a scale
Standard Deviation 1.09
|
2.2 units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16Population: Full Analysis Population
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Baseline (n=282, 284)
|
3.6 units on a scale
Standard Deviation 2.76
|
3.8 units on a scale
Standard Deviation 2.81
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 4 (n=281, 283)
|
3.0 units on a scale
Standard Deviation 2.54
|
3.5 units on a scale
Standard Deviation 2.77
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 6 (n=270, 271)
|
2.6 units on a scale
Standard Deviation 2.41
|
3.3 units on a scale
Standard Deviation 2.85
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 8 (n=245, 241)
|
2.4 units on a scale
Standard Deviation 2.53
|
3.0 units on a scale
Standard Deviation 2.70
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 10 (n=207, 204)
|
2.4 units on a scale
Standard Deviation 2.48
|
2.7 units on a scale
Standard Deviation 2.60
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 12 (n=170, 181)
|
2.1 units on a scale
Standard Deviation 2.42
|
2.6 units on a scale
Standard Deviation 2.66
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 14 (n=151, 152)
|
2.0 units on a scale
Standard Deviation 2.35
|
2.5 units on a scale
Standard Deviation 2.54
|
|
Visual Analog Scale (VAS) - Overall Pain Severity
Week 16 (n=143, 152)
|
2.0 units on a scale
Standard Deviation 2.32
|
2.3 units on a scale
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population
The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=283 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Baseline (n=281, 283)
|
4.2 units on a scale
Standard Deviation 1.87
|
3.9 units on a scale
Standard Deviation 1.70
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Week 4 (n=282, 280)
|
4.9 units on a scale
Standard Deviation 1.76
|
4.5 units on a scale
Standard Deviation 1.62
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Week 8 (n=244, 237)
|
5.7 units on a scale
Standard Deviation 1.88
|
5.4 units on a scale
Standard Deviation 1.94
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Week 12 (n=169, 177)
|
5.9 units on a scale
Standard Deviation 1.96
|
5.8 units on a scale
Standard Deviation 1.98
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Week 16 (n=142, 153)
|
6.5 units on a scale
Standard Deviation 1.90
|
6.5 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population
The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Outcome measures
| Measure |
Early Intervention
n=279 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=282 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Baseline (n=279, 282)
|
0.4 units on a scale
Standard Deviation 0.29
|
0.3 units on a scale
Standard Deviation 0.31
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Week 4 (n=279, 282)
|
0.5 units on a scale
Standard Deviation 0.30
|
0.5 units on a scale
Standard Deviation 0.32
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Week 8 (n=244, 238)
|
0.7 units on a scale
Standard Deviation 0.25
|
0.6 units on a scale
Standard Deviation 0.30
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Week 12 (n=168, 178)
|
0.7 units on a scale
Standard Deviation 0.22
|
0.6 units on a scale
Standard Deviation 0.28
|
|
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Week 16 (n=143, 153)
|
0.7 units on a scale
Standard Deviation 0.24
|
0.7 units on a scale
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Outcome measures
| Measure |
Early Intervention
n=216 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=217 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Sheehan Disability Scale (SDS) Normal Functioning Total Score
Baseline (n=216, 217)
|
19.9 units on a scale
Standard Deviation 5.12
|
19.9 units on a scale
Standard Deviation 5.52
|
|
Sheehan Disability Scale (SDS) Normal Functioning Total Score
Week 4 (n=215, 215)
|
16.9 units on a scale
Standard Deviation 6.36
|
17.5 units on a scale
Standard Deviation 6.11
|
|
Sheehan Disability Scale (SDS) Normal Functioning Total Score
Week 8 (n=186, 188)
|
13.5 units on a scale
Standard Deviation 6.50
|
14.0 units on a scale
Standard Deviation 6.79
|
|
Sheehan Disability Scale (SDS) Normal Functioning Total Score
Week 12 (n=140, 144)
|
12.1 units on a scale
Standard Deviation 6.84
|
13.2 units on a scale
Standard Deviation 7.51
|
|
Sheehan Disability Scale (SDS) Normal Functioning Total Score
Week 16 (n=113, 121)
|
10.3 units on a scale
Standard Deviation 7.27
|
10.2 units on a scale
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Resource Utilisation - Number of Hours Worked Per Week
Week 4 (n=153, 159)
|
37.7 Hours
Standard Deviation 11.61
|
38.6 Hours
Standard Deviation 13.33
|
|
Resource Utilisation - Number of Hours Worked Per Week
Week 8 (n=136, 141)
|
37.9 Hours
Standard Deviation 9.08
|
37.7 Hours
Standard Deviation 8.42
|
|
Resource Utilisation - Number of Hours Worked Per Week
Week 12 (n=119, 115)
|
37.7 Hours
Standard Deviation 7.40
|
38.1 Hours
Standard Deviation 13.72
|
|
Resource Utilisation - Number of Hours Worked Per Week
Week 16 (n=96, 96)
|
37.2 Hours
Standard Deviation 7.80
|
38.0 Hours
Standard Deviation 14.74
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.
Only those participants who missed at least 1 hour of work were included.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Week 4 (n=73, 89)
|
88.6 Hours
Standard Deviation 64.30
|
95.0 Hours
Standard Deviation 67.40
|
|
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Week 8 (n=54, 67)
|
92.5 Hours
Standard Deviation 66.12
|
102.3 Hours
Standard Deviation 69.38
|
|
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Week 12 (n=38, 56)
|
85.0 Hours
Standard Deviation 65.73
|
104.5 Hours
Standard Deviation 68.72
|
|
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Week 16 (n=25, 39)
|
91.5 Hours
Standard Deviation 63.49
|
126.4 Hours
Standard Deviation 63.64
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.
Only those participants who missed at least 1 hour of work due to depression were included.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Week 4 (n=70, 86)
|
90.6 Hours
Standard Deviation 64.98
|
95.1 Hours
Standard Deviation 67.90
|
|
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Week 8 (n=47, 61)
|
98.5 Hours
Standard Deviation 65.34
|
109.7 Hours
Standard Deviation 68.08
|
|
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Week 12 (n=31, 52)
|
98.7 Hours
Standard Deviation 64.32
|
111.4 Hours
Standard Deviation 66.42
|
|
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Week 16 (n=24, 38)
|
91.9 Hours
Standard Deviation 64.99
|
126.0 Hours
Standard Deviation 63.40
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Week 4 (n=36, 55)
|
1.5 Visits
Standard Deviation 1.00
|
1.6 Visits
Standard Deviation 1.04
|
|
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Week 8 (n=14, 22)
|
1.1 Visits
Standard Deviation 0.27
|
1.7 Visits
Standard Deviation 1.13
|
|
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Week 12 (n=8, 12)
|
1.3 Visits
Standard Deviation 0.46
|
1.6 Visits
Standard Deviation 1.00
|
|
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Week 16 (n=4, 7)
|
2.0 Visits
Standard Deviation 2.00
|
1.6 Visits
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population, which included all randomized participants with at least 1 post-randomization assessment available after Week 4. For efficacy analyses, participants were included in the analysis if they had a baseline and a post-baseline (after Week 4) value of the variable in question.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Week 4 (n=25, 16)
|
2.2 Visits
Standard Deviation 2.05
|
1.7 Visits
Standard Deviation 0.87
|
|
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Week 8 (n=8, 8)
|
1.6 Visits
Standard Deviation 0.74
|
1.9 Visits
Standard Deviation 1.13
|
|
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Week 12 (n=3, 2)
|
1.7 Visits
Standard Deviation 1.15
|
1.0 Visits
Standard Deviation 0.00
|
|
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Week 16 (n=2, 1)
|
2.0 Visits
Standard Deviation 0.00
|
3.0 Visits
Standard Deviation NA
n=1 participant; therefore SD could not be calculated.
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 16Population: Full Analysis Population
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Week 4
|
1 participants
|
0 participants
|
|
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Week 8
|
0 participants
|
0 participants
|
|
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Week 12
|
0 participants
|
0 participants
|
|
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Week 16
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: Full Analysis Population
The list of AEs is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Early Intervention
n=282 Participants
Duloxetine flexible dose (60 or 120 milligrams \[mg\] daily) for 12 weeks
|
Delayed Intervention
n=284 Participants
Escitalopram flexible dose (10 to 20 milligrams \[mg\] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams \[mg\] daily) for 8 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Number of participants with adverse events
|
112 participants
|
101 participants
|
|
Number of Participants With Adverse Events (AEs)
Number of participants with serious adverse events
|
8 participants
|
4 participants
|
Adverse Events
Escitalopram (Acute Treatment)
Serious events: 4 serious events
Other events: 245 other events
Deaths: 0 deaths
Delayed Intervention (Double Blind)
Serious events: 4 serious events
Other events: 99 other events
Deaths: 0 deaths
Early Intervention (Double Blind)
Serious events: 8 serious events
Other events: 110 other events
Deaths: 0 deaths
Delayed Intervention Responders
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Delayed Intervention Non-Responders
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Escitalopram (Acute Treatment)
n=840 participants at risk
Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
|
Delayed Intervention (Double Blind)
n=284 participants at risk
Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule\[s\]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
|
Early Intervention (Double Blind)
n=282 participants at risk
Duloxetine flexible dose (60 or 120 milligram \[mg\] daily) for 12 weeks.
|
Delayed Intervention Responders
n=83 participants at risk
Escitalopram 10 to 20 mg per day for 8 weeks.
|
Delayed Intervention Non-Responders
n=165 participants at risk
Duloxetine 60 or 120 mg per day for 8 weeks.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Constipation
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Injury, poisoning and procedural complications
Drug exposure during pregnancy
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Depression
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Suicidal ideation
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
Other adverse events
| Measure |
Escitalopram (Acute Treatment)
n=840 participants at risk
Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
|
Delayed Intervention (Double Blind)
n=284 participants at risk
Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule\[s\]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
|
Early Intervention (Double Blind)
n=282 participants at risk
Duloxetine flexible dose (60 or 120 milligram \[mg\] daily) for 12 weeks.
|
Delayed Intervention Responders
n=83 participants at risk
Escitalopram 10 to 20 mg per day for 8 weeks.
|
Delayed Intervention Non-Responders
n=165 participants at risk
Duloxetine 60 or 120 mg per day for 8 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
10/840 • Number of events 10
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.4%
4/284 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
3/165 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
14/840 • Number of events 14
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.5%
7/282 • Number of events 7
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
16/840 • Number of events 16
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.1%
6/284 • Number of events 6
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.5%
7/282 • Number of events 7
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
4/165 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
26/840 • Number of events 28
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.1%
3/284 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
3.5%
10/282 • Number of events 10
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
2/83 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.71%
2/282 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Flatulence
|
0.36%
3/840 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
63/840 • Number of events 63
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/284 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
5.0%
14/282 • Number of events 14
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
4/165 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Gastrointestinal disorders
Vomiting
|
0.60%
5/840 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
General disorders
Fatigue
|
0.83%
7/840 • Number of events 7
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.5%
7/284 • Number of events 7
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.1%
6/282 • Number of events 6
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
4.8%
4/83 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
General disorders
Malaise
|
0.24%
2/840 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Immune system disorders
Seasonal allergy
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Infections and infestations
Influenza
|
0.36%
3/840 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.1%
3/284 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/282 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
2/83 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
10/840 • Number of events 10
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
4.2%
12/284 • Number of events 13
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/282 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
3.6%
3/83 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
5.5%
9/165 • Number of events 9
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Investigations
Biopsy uterus
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Investigations
Blood pressure diastolic decreased
|
0.36%
3/840 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/282 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Investigations
Weight decreased
|
0.48%
4/840 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.4%
4/284 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
2/83 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Investigations
Weight increased
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
2/83 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
3/840 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/284 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.71%
2/282 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.4%
4/165 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Nervous system disorders
Dizziness
|
1.8%
15/840 • Number of events 15
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/284 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
3.9%
11/282 • Number of events 11
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
3.6%
3/83 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Nervous system disorders
Headache
|
5.1%
43/840 • Number of events 51
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
8.5%
24/284 • Number of events 28
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
7.8%
22/282 • Number of events 43
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
6.0%
5/83 • Number of events 7
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
10.3%
17/165 • Number of events 19
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Nervous system disorders
Somnolence
|
0.71%
6/840 • Number of events 6
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Nervous system disorders
Tremor
|
0.83%
7/840 • Number of events 7
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.1%
3/282 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Anxiety
|
1.2%
10/840 • Number of events 10
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.1%
3/284 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.71%
2/282 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Insomnia
|
1.2%
10/840 • Number of events 10
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.4%
4/284 • Number of events 4
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.1%
6/282 • Number of events 9
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
3/165 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Loss of libido
|
0.36%
3/840 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Psychiatric disorders
Panic attack
|
0.24%
2/840 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
20/840 • Number of events 20
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
2.1%
6/284 • Number of events 6
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
4.3%
12/282 • Number of events 12
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
6.0%
5/83 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/840
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.71%
2/282 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Vascular disorders
Diastolic hypertension
|
0.12%
1/840 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/284 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/282
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Vascular disorders
Hot flush
|
0.24%
2/840 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/284
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/282 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/165
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Vascular disorders
Hypertension
|
2.3%
19/840 • Number of events 19
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.8%
5/282 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.00%
0/83
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
2/165 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
|
Vascular disorders
Hypotension
|
0.60%
5/840 • Number of events 5
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.70%
2/284 • Number of events 3
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.35%
1/282 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
1.2%
1/83 • Number of events 2
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
0.61%
1/165 • Number of events 1
Adverse events section reports events for participants in Period I (840) and Period II (282 early intervention, 284 delayed intervention). During Period II (Week 8), delayed intervention participants were subdivided by response to treatment (165 non-responders, 83 responders) and adverse events experienced by these participants are reported here.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60