Trial Outcomes & Findings for A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (NCT NCT01152554)
NCT ID: NCT01152554
Last Updated: 2014-04-11
Results Overview
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
COMPLETED
PHASE3
813 participants
Randomization (Week 0) to end of the follow-up period (Week 54)
2014-04-11
Participant Flow
This multicenter study was conducted in the US between 22 June 2010 and 07 February 2012.
The study had an up to 21-day screening/washout period, and an 6-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (a HAMD-17 total score of ≥10 and a CGI-S score ≥3).
Participant milestones
| Measure |
TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Overall Study
STARTED
|
610
|
203
|
|
Overall Study
Received Treatment
|
607
|
201
|
|
Overall Study
COMPLETED
|
276
|
92
|
|
Overall Study
NOT COMPLETED
|
334
|
111
|
Reasons for withdrawal
| Measure |
TC-5214
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
73
|
28
|
|
Overall Study
Eligiblity criteria not fulfilled
|
0
|
1
|
|
Overall Study
Adverse Event
|
67
|
14
|
|
Overall Study
Severe non-compliance to protocol
|
36
|
14
|
|
Overall Study
Condition under investigation worsened
|
5
|
2
|
|
Overall Study
Lack of Efficacy
|
20
|
3
|
|
Overall Study
Study-specific withdrawal criteria
|
17
|
8
|
|
Overall Study
Lost to Follow-up
|
87
|
32
|
|
Overall Study
Other
|
28
|
8
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
TC-5214
n=610 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=203 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
Total
n=813 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 11.75 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
418 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
566 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
467 participants
n=5 Participants
|
149 participants
n=7 Participants
|
616 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
121 participants
n=5 Participants
|
44 participants
n=7 Participants
|
165 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 participants
n=5 Participants
|
4 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization
|
18.4 Scores on a scale
STANDARD_DEVIATION 4.49 • n=5 Participants
|
18.6 Scores on a scale
STANDARD_DEVIATION 4.61 • n=7 Participants
|
18.5 Scores on a scale
STANDARD_DEVIATION 4.52 • n=5 Participants
|
|
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization
|
23.5 Scores on a scale
STANDARD_DEVIATION 6.34 • n=5 Participants
|
23.4 Scores on a scale
STANDARD_DEVIATION 5.85 • n=7 Participants
|
23.4 Scores on a scale
STANDARD_DEVIATION 6.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization (Week 0) to end of the follow-up period (Week 54)Population: Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.
The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
Outcome measures
| Measure |
TC-5214
n=607 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=201 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Frequency of Patients Experiencing at Least One Adverse Event (AE)
|
82.4 percentage of participants analyzed
|
84.6 percentage of participants analyzed
|
PRIMARY outcome
Timeframe: Randomization (Week 0) to end of the follow-up period (Week 54)Population: Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.
The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Outcome measures
| Measure |
TC-5214
n=607 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=201 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
|
10.5 percentage of participants analyzed
|
7.0 percentage of participants analyzed
|
PRIMARY outcome
Timeframe: Randomization (Week 0) to end of the follow-up period (Week 54)Population: Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.
The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.
Outcome measures
| Measure |
TC-5214
n=607 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=201 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Frequency of Patients Experiencing Serious Adverse Events (SAEs)
|
3.6 percentage of participants analyzed
|
2.5 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Week 12 to Week 24Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score \>12 but ≤16 or missing was allowed from Week 16 to Week 20. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
TC-5214
n=391 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=136 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24
|
18.2 percentage of participants analyzed
|
20.6 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Week 12 to Week 52Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS \>12 but ≤16 or missing were allowed from Week 16 to Week 48. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
TC-5214
n=391 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=136 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52
|
9.7 percentage of patients analyzed
|
12.5 percentage of patients analyzed
|
SECONDARY outcome
Timeframe: Randomization (Week 0) to end of treatment (Week 52)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.
Outcome measures
| Measure |
TC-5214
n=176 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=68 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)
|
-1.8 units on a scale
Standard Deviation 1.17
|
-1.6 units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Randomization (Week 0) to end of treatment (Week 52)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).
Outcome measures
| Measure |
TC-5214
n=185 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=70 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score
|
-6.98 units on a scale
Standard Deviation 7.909
|
-7.44 units on a scale
Standard Deviation 7.530
|
SECONDARY outcome
Timeframe: Randomization (Week 0) to end of treatment (Week 52)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.
Outcome measures
| Measure |
TC-5214
n=184 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=70 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score
|
10.83 units on a scale
Standard Deviation 18.744
|
11.62 units on a scale
Standard Deviation 17.006
|
SECONDARY outcome
Timeframe: Randomization (Week 0) to end of treatment (Week 52)Population: Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.
Outcome measures
| Measure |
TC-5214
n=177 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
Placebo
n=68 Participants
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
|
|---|---|---|
|
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
EQ-5D index score
|
0.081 units on a scale
Standard Deviation 0.2021
|
0.071 units on a scale
Standard Deviation 0.1500
|
|
Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
EQ-5D VAS score
|
8.7 units on a scale
Standard Deviation 20.04
|
11.9 units on a scale
Standard Deviation 21.06
|
Adverse Events
Placebo
TC-5214
Serious adverse events
| Measure |
Placebo
n=201 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
|
TC-5214
n=607 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/201
|
0.33%
2/607 • Number of events 2
|
|
Infections and infestations
Oral Infection
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Brain Contusion
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.50%
1/201 • Number of events 1
|
0.00%
0/607
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.50%
1/201 • Number of events 1
|
0.00%
0/607
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.50%
1/201 • Number of events 1
|
0.00%
0/607
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.50%
1/201 • Number of events 1
|
0.16%
1/607 • Number of events 1
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/201
|
0.33%
2/607 • Number of events 2
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/201
|
0.33%
2/607 • Number of events 2
|
|
Reproductive system and breast disorders
Ovarian Torsion
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.50%
1/201 • Number of events 1
|
0.00%
0/607
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.50%
1/201 • Number of events 1
|
0.00%
0/607
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/201
|
0.16%
1/607 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=201 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
|
TC-5214
n=607 participants at risk
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.0%
6/201 • Number of events 7
|
2.1%
13/607 • Number of events 13
|
|
Gastrointestinal disorders
Constipation
|
6.0%
12/201 • Number of events 14
|
19.8%
120/607 • Number of events 147
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
20/201 • Number of events 23
|
10.7%
65/607 • Number of events 80
|
|
Gastrointestinal disorders
Nausea
|
11.9%
24/201 • Number of events 27
|
10.5%
64/607 • Number of events 79
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
10/201 • Number of events 11
|
9.7%
59/607 • Number of events 61
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
13/201 • Number of events 21
|
5.3%
32/607 • Number of events 40
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.0%
4/201 • Number of events 4
|
2.0%
12/607 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.00%
2/201 • Number of events 2
|
2.3%
14/607 • Number of events 16
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
4/201 • Number of events 4
|
2.3%
14/607 • Number of events 15
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.0%
4/201 • Number of events 5
|
0.82%
5/607 • Number of events 5
|
|
General disorders
Fatigue
|
8.5%
17/201 • Number of events 18
|
6.4%
39/607 • Number of events 43
|
|
Immune system disorders
Seasonal Allergy
|
2.5%
5/201 • Number of events 5
|
1.8%
11/607 • Number of events 12
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
14.9%
30/201 • Number of events 39
|
17.1%
104/607 • Number of events 122
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
22/201 • Number of events 26
|
9.7%
59/607 • Number of events 70
|
|
Infections and infestations
Sinusitis
|
5.5%
11/201 • Number of events 14
|
4.6%
28/607 • Number of events 32
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
10/201 • Number of events 11
|
4.3%
26/607 • Number of events 30
|
|
Infections and infestations
Influenza
|
3.5%
7/201 • Number of events 8
|
3.1%
19/607 • Number of events 22
|
|
Infections and infestations
Bronchitis
|
2.5%
5/201 • Number of events 5
|
2.0%
12/607 • Number of events 12
|
|
Infections and infestations
Gastroenteritis
|
2.5%
5/201 • Number of events 6
|
2.3%
14/607 • Number of events 14
|
|
Infections and infestations
Gastroenteritis Viral
|
2.5%
5/201 • Number of events 5
|
2.1%
13/607 • Number of events 13
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
6/201 • Number of events 6
|
0.82%
5/607 • Number of events 5
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
2.0%
4/201 • Number of events 4
|
1.2%
7/607 • Number of events 7
|
|
Injury, poisoning and procedural complications
Weight Increased
|
7.0%
14/201 • Number of events 14
|
4.4%
27/607 • Number of events 27
|
|
Injury, poisoning and procedural complications
Blood Pressure Increased
|
2.5%
5/201 • Number of events 6
|
1.3%
8/607 • Number of events 9
|
|
Metabolism and nutrition disorders
Increased Appetite
|
2.5%
5/201 • Number of events 5
|
1.8%
11/607 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
10/201 • Number of events 12
|
4.3%
26/607 • Number of events 35
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.0%
18/201 • Number of events 21
|
3.3%
20/607 • Number of events 23
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.5%
5/201 • Number of events 5
|
2.5%
15/607 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.0%
4/201 • Number of events 4
|
1.8%
11/607 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.0%
4/201 • Number of events 5
|
1.8%
11/607 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
7/201 • Number of events 8
|
1.5%
9/607 • Number of events 11
|
|
Nervous system disorders
Headache
|
16.9%
34/201 • Number of events 52
|
16.8%
102/607 • Number of events 170
|
|
Nervous system disorders
Dizziness
|
8.0%
16/201 • Number of events 24
|
12.4%
75/607 • Number of events 99
|
|
Nervous system disorders
Dizziness Postural
|
1.5%
3/201 • Number of events 3
|
4.6%
28/607 • Number of events 43
|
|
Nervous system disorders
Somnolence
|
4.5%
9/201 • Number of events 9
|
5.1%
31/607 • Number of events 33
|
|
Nervous system disorders
Sedation
|
2.0%
4/201 • Number of events 4
|
2.0%
12/607 • Number of events 12
|
|
Nervous system disorders
Memory Impairment
|
2.0%
4/201 • Number of events 4
|
0.82%
5/607 • Number of events 6
|
|
Nervous system disorders
Migraine
|
2.5%
5/201 • Number of events 5
|
1.3%
8/607 • Number of events 8
|
|
Nervous system disorders
Paraesthesia
|
2.5%
5/201 • Number of events 6
|
1.2%
7/607 • Number of events 7
|
|
Nervous system disorders
Tremor
|
2.0%
4/201 • Number of events 4
|
0.82%
5/607 • Number of events 5
|
|
Psychiatric disorders
Insomnia
|
9.0%
18/201 • Number of events 20
|
7.7%
47/607 • Number of events 52
|
|
Psychiatric disorders
Abnormal Dreams
|
3.5%
7/201 • Number of events 7
|
4.6%
28/607 • Number of events 29
|
|
Psychiatric disorders
Agitation
|
2.5%
5/201 • Number of events 6
|
3.5%
21/607 • Number of events 22
|
|
Psychiatric disorders
Anxiety
|
0.50%
1/201 • Number of events 1
|
2.5%
15/607 • Number of events 17
|
|
Psychiatric disorders
Bruxism
|
2.0%
4/201 • Number of events 4
|
0.49%
3/607 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
5/201 • Number of events 5
|
2.5%
15/607 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.0%
4/201 • Number of events 5
|
1.8%
11/607 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.5%
5/201 • Number of events 5
|
2.1%
13/607 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
4/201 • Number of events 4
|
0.16%
1/607 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.5%
5/201 • Number of events 5
|
2.8%
17/607 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
4/201 • Number of events 4
|
0.99%
6/607 • Number of events 6
|
|
Vascular disorders
Hypertension
|
4.5%
9/201 • Number of events 9
|
2.5%
15/607 • Number of events 15
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/201
|
2.1%
13/607 • Number of events 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60