Trial Outcomes & Findings for A Study of Ketamine in Patients With Treatment-resistant Depression (NCT NCT01627782)
NCT ID: NCT01627782
Last Updated: 2025-04-29
Results Overview
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Baseline (Day 1) and Day 15
Results posted on
2025-04-29
Participant Flow
A total of 165 participants were screened and 68 participants were randomized into the study. Of these 68 participants randomized, 67 participants received at least 1 dose of the study agent (Intent-To-Treat analysis set).
Participant milestones
| Measure |
Placebo: 2 Times Per Week
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
16
|
17
|
|
Overall Study
Treated
|
16
|
18
|
16
|
17
|
|
Overall Study
COMPLETED
|
1
|
12
|
1
|
11
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
15
|
6
|
Reasons for withdrawal
| Measure |
Placebo: 2 Times Per Week
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
11
|
1
|
15
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
2
|
0
|
3
|
|
Overall Study
Randomized But Not Treated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Ketamine in Patients With Treatment-resistant Depression
Baseline characteristics by cohort
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 years
STANDARD_DEVIATION 11.79 • n=5 Participants
|
45.7 years
STANDARD_DEVIATION 9.58 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 11.99 • n=4 Participants
|
43.9 years
STANDARD_DEVIATION 10.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Region of Enrollment
USA
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
16 participants
n=5 Participants
|
17 participants
n=4 Participants
|
67 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15
Baseline (n=16,18,16,17)
|
35.6 Units on a scale
Standard Deviation 3.79
|
33.3 Units on a scale
Standard Deviation 4.91
|
36.8 Units on a scale
Standard Deviation 5.83
|
35.4 Units on a scale
Standard Deviation 5.28
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15
Change at Day 15 (n=13,16,16,13)
|
-5.7 Units on a scale
Standard Deviation 10.23
|
-18.4 Units on a scale
Standard Deviation 12.01
|
-3.1 Units on a scale
Standard Deviation 5.67
|
-17.7 Units on a scale
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 29Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29
Change at Day 29 (n=2,13,1,13)
|
-23.5 Units on a scale
Standard Deviation 10.61
|
-27.1 Units on a scale
Standard Deviation 6.60
|
-1 Units on a scale
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
-22.9 Units on a scale
Standard Deviation 10.61
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29
Baseline (n=16,18,16,17)
|
35.6 Units on a scale
Standard Deviation 3.79
|
33.3 Units on a scale
Standard Deviation 4.91
|
36.8 Units on a scale
Standard Deviation 5.83
|
35.4 Units on a scale
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Day 15 and Day 29Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
Participants with a reduction in the MADRS total score of greater than or equal to (\>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=13 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=16 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=13 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Day 15 (n=13,16,16,13)
|
2 Participants
3.79
|
11 Participants
4.91
|
1 Participants
5.83
|
7 Participants
5.28
|
|
Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Day 29 (n=2,13,1,13)
|
1 Participants
10.61
|
13 Participants
6.60
|
0 Participants
NA
|
9 Participants
10.61
|
SECONDARY outcome
Timeframe: Day 15 and Day 29Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
Participants who had a MADRS total score of less than or equal to (\<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=13 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=16 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=13 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Day 15 (n=13,16,16,13)
|
1 Participants
3.79
|
6 Participants
4.91
|
0 Participants
5.83
|
3 Participants
5.28
|
|
Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Day 29 (n=2,13,1,13)
|
1 Participants
10.61
|
12 Participants
6.60
|
0 Participants
NA
|
5 Participants
10.61
|
SECONDARY outcome
Timeframe: Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
1 Participants
3.79
|
7 Participants
4.91
|
0 Participants
5.83
|
4 Participants
5.28
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Endpoint (Day 29)Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=15 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)
Baseline (n=15,18,16,17)
|
5.0 Units on a scale
Full Range 3.79 • Interval 4.0 to 6.0
|
5.0 Units on a scale
Full Range 4.91 • Interval 4.0 to 6.0
|
5.0 Units on a scale
Full Range 5.83 • Interval 4.0 to 6.0
|
5.0 Units on a scale
Full Range 5.28 • Interval 4.0 to 6.0
|
|
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)
Change at Endpoint (n=15,18,16,17)
|
0.0 Units on a scale
Full Range 10.61 • Interval -4.0 to 0.0
|
-2.0 Units on a scale
Full Range 6.60 • Interval -4.0 to 1.0
|
0.0 Units on a scale
Full Range NA • Interval -1.0 to 1.0
|
-2.0 Units on a scale
Full Range 10.61 • Interval -4.0 to 0.0
|
SECONDARY outcome
Timeframe: Endpoint (Day 29)Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase
|
4.0 Units on a scale
Full Range 3.79 • Interval 1.0 to 5.0
|
2.0 Units on a scale
Full Range 4.91 • Interval 1.0 to 5.0
|
4.0 Units on a scale
Full Range 5.83 • Interval 2.0 to 5.0
|
2.0 Units on a scale
Full Range 5.28 • Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Endpoint (Day 29)Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=15 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)
Baseline (n=15,18,16,17)
|
8.0 Units on a scale
Full Range 3.79 • Interval 4.0 to 9.0
|
7.5 Units on a scale
Full Range 4.91 • Interval 5.0 to 9.0
|
8.0 Units on a scale
Full Range 5.83 • Interval 5.0 to 10.0
|
7.0 Units on a scale
Full Range 5.28 • Interval 5.0 to 9.0
|
|
Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)
Change at Endpoint (n=15,18,16,17)
|
0.0 Units on a scale
Full Range 10.61 • Interval -3.0 to 2.0
|
-4.0 Units on a scale
Full Range 6.60 • Interval -8.0 to 0.0
|
-1.0 Units on a scale
Full Range NA • Interval -3.0 to 1.0
|
-3.0 Units on a scale
Full Range 10.61 • Interval -8.0 to 1.0
|
SECONDARY outcome
Timeframe: Endpoint (Day 29)Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 Participants
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 Participants
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase
|
4.0 Units on a scale
Full Range 3.79 • Interval 2.0 to 6.0
|
2.0 Units on a scale
Full Range 4.91 • Interval 1.0 to 4.0
|
4.0 Units on a scale
Full Range 5.83 • Interval 3.0 to 6.0
|
3.0 Units on a scale
Full Range 5.28 • Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The Cmax is the maximum observed plasma concentration of drug.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=16 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Ketamine
Day 1 (n=16,16)
|
207 nanogram per milliliter (ng/ml)
Standard Deviation 83.0 • Interval 5.0 to 9.0
|
168 nanogram per milliliter (ng/ml)
Standard Deviation 34.4 • Interval 5.0 to 9.0
|
—
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Ketamine
Day 15 (n=14,15)
|
219 nanogram per milliliter (ng/ml)
Standard Deviation 69.4 • Interval -8.0 to 0.0
|
189 nanogram per milliliter (ng/ml)
Standard Deviation 74.4 • Interval -8.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The Tmax is defined as actual sampling time to reach maximum observed drug concentration.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=16 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine
Day 1 (n=16,16)
|
0.67 Hour
Full Range 83.0 • Interval 0.63 to 0.83
|
0.66 Hour
Full Range 34.4 • Interval 0.33 to 0.75
|
—
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine
Day 15 (n=14,15)
|
0.67 Hour
Full Range 69.4 • Interval 0.63 to 1.0
|
0.67 Hour
Full Range 74.4 • Interval 0.5 to 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=16 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=15 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])
Day 1 (n=16,15)
|
312 hour*nanogram per milliliter
Standard Deviation 67.9 • Interval 0.63 to 0.83
|
295 hour*nanogram per milliliter
Standard Deviation 42.8 • Interval 0.33 to 0.75
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])
Day 15 (n=14,14)
|
342 hour*nanogram per milliliter
Standard Deviation 66.7 • Interval 0.63 to 1.0
|
293 hour*nanogram per milliliter
Standard Deviation 65.6 • Interval 0.5 to 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=13 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=13 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Day 1 (n=13,13)
|
369 hour*nanogram per milliliter
Standard Deviation 79.9 • Interval 0.63 to 0.83
|
344 hour*nanogram per milliliter
Standard Deviation 47.3 • Interval 0.33 to 0.75
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Day 15 (n=9,8)
|
416 hour*nanogram per milliliter
Standard Deviation 68.9 • Interval 0.63 to 1.0
|
340 hour*nanogram per milliliter
Standard Deviation 94.0 • Interval 0.5 to 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=13 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=13 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Total Systemic Clearance (CL) of Ketamine
Day 1 (n=13,13)
|
113 liter per hour
Standard Deviation 35.1 • Interval 0.63 to 0.83
|
108 liter per hour
Standard Deviation 21.4 • Interval 0.33 to 0.75
|
—
|
—
|
|
Total Systemic Clearance (CL) of Ketamine
Day 15 (n=9,8)
|
93.9 liter per hour
Standard Deviation 15.6 • Interval 0.63 to 1.0
|
117 liter per hour
Standard Deviation 22.3 • Interval 0.5 to 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state.
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=13 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=13 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Volume of Distribution at Steady-State (Vss) of Ketamine
Day 1 (n=13,13)
|
275 liter
Standard Deviation 114 • Interval 0.63 to 0.83
|
276 liter
Standard Deviation 77.2 • Interval 0.33 to 0.75
|
—
|
—
|
|
Volume of Distribution at Steady-State (Vss) of Ketamine
Day 15 (n=9,8)
|
239 liter
Standard Deviation 61.2 • Interval 0.63 to 1.0
|
290 liter
Standard Deviation 64.9 • Interval 0.5 to 0.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15Population: An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,"N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point, respectively
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Outcome measures
| Measure |
Placebo: 2 Times Per Week
n=13 Participants
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=13 Participants
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Elimination Half-Life (t1/2)
Day 1 (n=13,13)
|
2.18 hour
Standard Deviation 0.43 • Interval 0.63 to 0.83
|
2.18 hour
Standard Deviation 0.40 • Interval 0.33 to 0.75
|
—
|
—
|
|
Elimination Half-Life (t1/2)
Day 15 (n=9,8)
|
2.39 hour
Standard Deviation 0.36 • Interval 0.63 to 1.0
|
2.21 hour
Standard Deviation 0.36 • Interval 0.5 to 0.83
|
—
|
—
|
Adverse Events
Placebo: 2 Times Per Week
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ketamine: 2 Times Per Week
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo: 3 Times Per Week
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ketamine: 3 Times Per Week
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: 2 Times Per Week
n=16 participants at risk
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 participants at risk
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 participants at risk
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 participants at risk
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
Other adverse events
| Measure |
Placebo: 2 Times Per Week
n=16 participants at risk
Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
|
Ketamine: 2 Times Per Week
n=18 participants at risk
Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
|
Placebo: 3 Times Per Week
n=16 participants at risk
Participants received IV infusion of placebo 3 times weekly for 4 weeks.
|
Ketamine: 3 Times Per Week
n=17 participants at risk
Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Flutter
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Eye disorders
Altered Visual Depth Perception
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.1%
2/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
16.7%
3/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
12.5%
2/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
23.5%
4/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.8%
2/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Feeling Abnormal
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Feeling Cold
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Inflammation
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Infusion Site Pain
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Injection Site Extravasation
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
General disorders
Irritability
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.1%
2/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Investigations
Drug Screen Positive
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Investigations
Electrocardiogram St-T Change
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Investigations
Weight Decreased
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
22.2%
4/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.8%
2/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dizziness Postural
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Headache
|
31.2%
5/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
22.2%
4/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
41.2%
7/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.1%
2/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
17.6%
3/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.8%
2/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Poor Quality Sleep
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Sedation
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
22.2%
4/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Disorientation
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
27.8%
5/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Dissociative Disorder
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Hallucination, Tactile
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Hallucination, Visual
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Renal and urinary disorders
Dysuria
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
6.2%
1/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.6%
1/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
11.1%
2/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/18 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
0.00%
0/16 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
5.9%
1/17 • Screening up to Follow up (3 Weeks After Last Dose of Study Drug Administration)
The safety analysis set is defined as all participants who received at least 1 dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER