Trial Outcomes & Findings for A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder (NCT NCT01482221)
NCT ID: NCT01482221
Last Updated: 2017-04-11
Results Overview
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
542 participants
Primary outcome timeframe
Baseline to Week 6
Results posted on
2017-04-11
Participant Flow
This multicenter study was conducted in Chile, Slovakia, South Africa, and the United States between 16 December 2011 and 26 August 2013. A total of 542 patients were enrolled in the study and of these, 302 patients were randomized to treatment. 240 patients were not randomized to treatment due to eligibility criteria not being fulfilled.
The study had a screening/washout period of up to 42 days, a 12-week double blind treatment period, and a 14-day follow-up period. Patients received 3 infusions per week during Weeks 1 to 3,1 infusion per week during Weeks 4 to 6, and 1 infusion every other week during Weeks 7 to 12.
Participant milestones
| Measure |
AZD6765 50 mg
Intravenous infusion
|
AZD6765 100 mg
Intravenous infusion
|
Placebo
Intravenous infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
100
|
|
Overall Study
COMPLETED
|
80
|
81
|
77
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
23
|
Reasons for withdrawal
| Measure |
AZD6765 50 mg
Intravenous infusion
|
AZD6765 100 mg
Intravenous infusion
|
Placebo
Intravenous infusion
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
|
Overall Study
Study-Specific Withdrawal Criteria
|
2
|
0
|
1
|
|
Overall Study
Condition under Investigation Worsened
|
3
|
2
|
4
|
|
Overall Study
Severe Non-Compliance to Protocol
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
7
|
12
|
|
Overall Study
Incorrect randomization
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=101 Participants
Intravenous infusion
|
Placebo
n=100 Participants
Intravenous infusion
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.7 Years
STANDARD_DEVIATION 11.19 • n=5 Participants
|
47.5 Years
STANDARD_DEVIATION 11.89 • n=7 Participants
|
49.5 Years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
48.2 Years
STANDARD_DEVIATION 11.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
91 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: The modified intent-to-treat (mITT) analysis set included all randomized patients, who took investigational product (IP) and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=100 Participants
Intravenous infusion
|
Placebo
n=97 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-14.37 units on a scale
Standard Error 1.238
|
-14.40 units on a scale
Standard Error 1.244
|
-13.18 units on a scale
Standard Error 1.266
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The modified intent-to-treat (mITT) analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
Outcome measures
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=100 Participants
Intravenous infusion
|
Placebo
n=97 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-15.97 units on a scale
Standard Error 1.313
|
-13.03 units on a scale
Standard Error 1.332
|
-13.92 units on a scale
Standard Error 1.354
|
SECONDARY outcome
Timeframe: Week 6 to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.
Outcome measures
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=100 Participants
Intravenous infusion
|
Placebo
n=97 Participants
Intravenous infusion
|
|---|---|---|---|
|
Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)
|
22.8 percentage of participants analyzed
|
23.0 percentage of participants analyzed
|
21.6 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
Outcome measures
| Measure |
AZD6765 50 mg
n=86 Participants
Intravenous infusion
|
AZD6765 100 mg
n=84 Participants
Intravenous infusion
|
Placebo
n=82 Participants
Intravenous infusion
|
|---|---|---|---|
|
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6
|
36.0 percentage of participants analyzed
|
44.0 percentage of participants analyzed
|
39.0 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.
Outcome measures
| Measure |
AZD6765 50 mg
n=89 Participants
Intravenous infusion
|
AZD6765 100 mg
n=85 Participants
Intravenous infusion
|
Placebo
n=81 Participants
Intravenous infusion
|
|---|---|---|---|
|
Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12
|
48.3 percentage of participants analyzed
|
36.5 percentage of participants analyzed
|
40.7 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
Outcome measures
| Measure |
AZD6765 50 mg
n=86 Participants
Intravenous infusion
|
AZD6765 100 mg
n=84 Participants
Intravenous infusion
|
Placebo
n=82 Participants
Intravenous infusion
|
|---|---|---|---|
|
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6
|
23.3 percentage of participants analyzed
|
23.8 percentage of participants analyzed
|
18.3 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.
Outcome measures
| Measure |
AZD6765 50 mg
n=89 Participants
Intravenous infusion
|
AZD6765 100 mg
n=85 Participants
Intravenous infusion
|
Placebo
n=81 Participants
Intravenous infusion
|
|---|---|---|---|
|
Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12
|
27.0 percentage of participants analyzed
|
22.4 percentage of participants analyzed
|
25.9 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).
Outcome measures
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=100 Participants
Intravenous infusion
|
Placebo
n=97 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Week 6
|
-7.08 units on a scale
Standard Error 0.959
|
-6.90 units on a scale
Standard Error 0.981
|
-6.91 units on a scale
Standard Error 0.989
|
|
Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Week 12
|
-6.98 units on a scale
Standard Error 0.995
|
-6.80 units on a scale
Standard Error 1.021
|
-8.09 units on a scale
Standard Error 1.034
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient's illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).
Outcome measures
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=100 Participants
Intravenous infusion
|
Placebo
n=97 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score
Week 6
|
-1.5 units on a scale
Standard Error 0.16
|
-1.5 units on a scale
Standard Error 0.16
|
-1.4 units on a scale
Standard Error 0.16
|
|
Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score
Week 12
|
-1.8 units on a scale
Standard Error 0.16
|
-1.5 units on a scale
Standard Error 0.16
|
-1.6 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores \>4 indicate worsening, while scores \<4 indicate improvement.
Outcome measures
| Measure |
AZD6765 50 mg
n=86 Participants
Intravenous infusion
|
AZD6765 100 mg
n=84 Participants
Intravenous infusion
|
Placebo
n=82 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 6
|
51.2 percentage of participants analyzed
|
47.6 percentage of participants analyzed
|
37.8 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores \>4 indicate worsening, while scores \<4 indicate improvement.
Outcome measures
| Measure |
AZD6765 50 mg
n=89 Participants
Intravenous infusion
|
AZD6765 100 mg
n=85 Participants
Intravenous infusion
|
Placebo
n=81 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of "Very Much Improved" or "Much Improved") at Week 12
|
50.6 percentage of participants analyzed
|
44.7 percentage of participants analyzed
|
40.7 percentage of participants analyzed
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.
A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).
Outcome measures
| Measure |
AZD6765 50 mg
n=101 Participants
Intravenous infusion
|
AZD6765 100 mg
n=100 Participants
Intravenous infusion
|
Placebo
n=97 Participants
Intravenous infusion
|
|---|---|---|---|
|
Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score
Week 12
|
-9.2 units on a scale
Standard Error 0.70
|
-7.6 units on a scale
Standard Error 0.71
|
-8.9 units on a scale
Standard Error 0.72
|
|
Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score
Week 6
|
-8.7 units on a scale
Standard Error 0.69
|
-7.9 units on a scale
Standard Error 0.70
|
-8.1 units on a scale
Standard Error 0.71
|
Adverse Events
AZD6765iv 100 mg
Serious events: 4 serious events
Other events: 68 other events
Deaths: 0 deaths
AZD6765iv 50 mg
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD6765iv 100 mg
n=100 participants at risk
Intravenous infusion
|
AZD6765iv 50 mg
n=101 participants at risk
Intravenous infusion
|
Placebo
n=100 participants at risk
Intravenous infusion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.99%
1/101 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Infections and infestations
HEPATITIS C
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
DEPRESSIVE SYMPTOM
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
INTENTIONAL DRUG MISUSE
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/101
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.99%
1/101 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
Other adverse events
| Measure |
AZD6765iv 100 mg
n=100 participants at risk
Intravenous infusion
|
AZD6765iv 50 mg
n=101 participants at risk
Intravenous infusion
|
Placebo
n=100 participants at risk
Intravenous infusion
|
|---|---|---|---|
|
Gastrointestinal disorders
CONSTIPATION
|
6.0%
6/100 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
2.0%
2/101 • Number of events 2
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/100 • Number of events 5
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.0%
5/100 • Number of events 7
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
6.9%
7/101 • Number of events 10
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/100 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.0%
6/100 • Number of events 17
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
3.0%
3/101 • Number of events 5
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
2.0%
2/100 • Number of events 3
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Gastrointestinal disorders
NAUSEA
|
21.0%
21/100 • Number of events 26
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
12.9%
13/101 • Number of events 13
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
13.0%
13/100 • Number of events 16
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
General disorders
FATIGUE
|
6.0%
6/100 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/101 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/100 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
General disorders
FEELING DRUNK
|
6.0%
6/100 • Number of events 38
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.99%
1/101 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
0.00%
0/100
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.0%
6/100 • Number of events 7
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
6.9%
7/101 • Number of events 8
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
4.0%
4/100 • Number of events 4
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.0%
1/100 • Number of events 1
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
6.9%
7/101 • Number of events 9
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
2.0%
2/100 • Number of events 2
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Nervous system disorders
DIZZINESS
|
45.0%
45/100 • Number of events 205
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
26.7%
27/101 • Number of events 63
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
10.0%
10/100 • Number of events 17
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Nervous system disorders
HEADACHE
|
17.0%
17/100 • Number of events 29
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
19.8%
20/101 • Number of events 28
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
18.0%
18/100 • Number of events 28
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Nervous system disorders
SEDATION
|
7.0%
7/100 • Number of events 26
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/101 • Number of events 18
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/100 • Number of events 13
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Nervous system disorders
SOMNOLENCE
|
6.0%
6/100 • Number of events 12
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
8.9%
9/101 • Number of events 16
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
7.0%
7/100 • Number of events 9
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
DISSOCIATION
|
8.0%
8/100 • Number of events 37
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
4.0%
4/101 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
4.0%
4/100 • Number of events 7
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
|
Psychiatric disorders
INSOMNIA
|
6.0%
6/100 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
5.0%
5/101 • Number of events 6
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
4.0%
4/100 • Number of events 4
The AZD6765iv (intravenous) 100 mg group had one less subject than the numbers provided in the Participant Flow Module because one subject who was randomized did not receive any study medication and thus was excluded from the efficacy and safety analysis sets.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60