Trial Outcomes & Findings for Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD (NCT NCT02634177)
NCT ID: NCT02634177
Last Updated: 2020-08-28
Results Overview
SIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
Baseline to 8 Weeks
Results posted on
2020-08-28
Participant Flow
304 Randomized
Participant milestones
| Measure |
Assay-guided Treatment (AGT)
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
153
|
|
Overall Study
COMPLETED
|
140
|
141
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD
Baseline characteristics by cohort
| Measure |
Treatment-as-usual (TAU)
n=153 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
Total
n=304 Participants
Total of all reporting groups
|
Assay-guided Treatment (AGT)
n=151 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 12.03 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 12.20 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=7 Participants
|
304 participants
n=5 Participants
|
151 participants
n=5 Participants
|
|
Body Weight (kg) at Screening
|
89.28 kg
STANDARD_DEVIATION 24.787 • n=7 Participants
|
88.93 kg
STANDARD_DEVIATION 23.566 • n=5 Participants
|
88.59 kg
STANDARD_DEVIATION 22.338 • n=5 Participants
|
|
Height at Screening
|
168.0 cm
STANDARD_DEVIATION 9.41 • n=7 Participants
|
168.1 cm
STANDARD_DEVIATION 10.03 • n=5 Participants
|
168.3 cm
STANDARD_DEVIATION 10.64 • n=5 Participants
|
|
BMI at Screening
|
31.62 kg/m^2
STANDARD_DEVIATION 8.443 • n=7 Participants
|
31.45 kg/m^2
STANDARD_DEVIATION 7.973 • n=5 Participants
|
31.27 kg/m^2
STANDARD_DEVIATION 7.491 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 WeeksSIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=138 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=140 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Mean Change From Baseline in SIGH-D-17 Score at 8 Weeks.
|
-9.70 units on a scale
Standard Deviation 6.411
|
-10.16 units on a scale
Standard Deviation 6.689
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksQIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=138 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=141 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Mean Change From Baseline in QIDS-SR16 Score at 8 Weeks.
|
-6.04 units on a scale
Standard Deviation 5.407
|
-6.45 units on a scale
Standard Deviation 5.135
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksSIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=138 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=140 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of SIGH-D-17 Score From Baseline.
|
58 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksQIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=140 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=141 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Percentage of Treatment Responders at Week 8 Based on ≥ 50% Reduction of QIDS-SR16 Score From Baseline.
|
57 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksCGI-I: Clinical Global Impression Improvement scale; a clinician-rated scale that measures the improvement or worsening of a patient's symptoms The CGI-I is rated on a 7-point scale, with the improvement in severity of illness scale using a range of responses from 1 (Very much improved) through to 7 (Very much worse). A score of 0 indicates Patient was not able to be assessed
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=140 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=141 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Percentage of Treatment Responders at Week 8 Based on ≤ 3 Score on the CGI-I.
|
128 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksSIGH-D-17: 17-item rater-administered Structured Interview Guide of the Hamilton Depression Rating Scale Scoring is based on the 17-item scale and scores range from 0 minimum to 52 maximum. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=138 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=140 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Percentage of Remitters at Week 8 Based on ≤ 7 Score on the SIGH-D-17.
|
35 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksQIDS-SR16: 16-item Quick Inventory of Depressive Symptomatology Self-Report QIDS-SR16 ranges from a score of 0 minimum to 27 maximum. In terms of severity of depression, Scores of 0 to 5 reflect "none", scores of 6 to 15 reflect "mild", scores of 7-20 reflect "moderate and scores of 21 to 27 reflect "severe" depression.
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=140 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=141 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Percentage of Remitters at Week 8 Based on ≤ 5 Score on the QIDS-SR16.
|
43 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksA 3-question patient-rated scale for assessing frequency, intensity, and burden of medication side effects for patients receiving treatment for depression. The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale. A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s).
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=124 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=127 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Safety Outcomes Based on Frequency, Intensity and Burden of Side Effects Rating (FIBSER).
|
-.02 units on a scale
Standard Deviation 1.55
|
-.02 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Screening to 8 WeeksUntoward medical occurrence in a subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with treatment. As based on FIBSER The Frequency, Intensity, and Burden of Side Effects-Rating (FIBSER) questionnaire uses 3 questions with a 6-point Likert measurement scale. A score of 0-2 on question 3 (burden of side effects) represents an acceptable low side-effect burden usually requiring no treatment adjustment. A score of 3 or 4 indicates moderate side-effect burden that should be evaluated further (eg, timing related to dose change, patient concerns, etc), and an adjustment such as a dose decrease considered. A score of 5 or 6 indicates a high burden warranting a change such as dose decrease, switching, or direct treatment of the side effect(s). Scores refer to intensity, frequency and interference.
Outcome measures
| Measure |
Assay-guided Treatment (AGT)
n=124 Participants
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=127 Participants
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.
Frequency of the side effects for the past week
|
-0.1 score on a scale
Standard Deviation 2.18
|
-0.2 score on a scale
Standard Deviation 2.18
|
|
Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.
Intensity of the side effects over the last week
|
0.0 score on a scale
Standard Deviation 1.86
|
0.0 score on a scale
Standard Deviation 1.9
|
|
Safety Outcomes Based on Frequency and Severity of Reported Adverse Events.
Interference of day-to-day functions over the last
|
-0.2 score on a scale
Standard Deviation 1.55
|
-0.2 score on a scale
Standard Deviation 1.59
|
Adverse Events
Assay-guided Treatment (AGT)
Serious events: 6 serious events
Other events: 107 other events
Deaths: 0 deaths
Treatment-as-usual (TAU)
Serious events: 3 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Assay-guided Treatment (AGT)
n=150 participants at risk
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=153 participants at risk
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Appendicitis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Streptococcal sepsis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Syncope
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
Other adverse events
| Measure |
Assay-guided Treatment (AGT)
n=150 participants at risk
Assay results will be provided to the treating investigator, who will use the results to guide pharmacotherapy of the subject's MDD treatment.
Assay-guided treatment (AGT): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
|
Treatment-as-usual (TAU)
n=153 participants at risk
The treating investigator will treat subjects of the TAU group without the knowledge of the pharmacogenetic testing results.
Treatment-as-usual (TAU): Subjects are treated-as-usual without the aid of the assay.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Fatigue
|
4.0%
6/150 • Number of events 6 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Chest pain
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Edema peripheral
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Chest discomfort
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Crying
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Feeling hot
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
General disorders
Pyrexia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Metabolism and nutrition disorders
Increased appetite
|
4.7%
7/150 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
3.3%
5/153 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
3.3%
5/153 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Renal and urinary disorders
Pollakiuria
|
3.3%
5/150 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Headache
|
14.7%
22/150 • Number of events 22 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
9.8%
15/153 • Number of events 15 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Dizziness
|
8.7%
13/150 • Number of events 13 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
12.4%
19/153 • Number of events 19 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Somnolence
|
3.3%
5/150 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
6.5%
10/153 • Number of events 10 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Sedation
|
4.7%
7/150 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Coordination abnormal
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
3.9%
6/153 • Number of events 6 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Tremor
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
3.9%
6/153 • Number of events 6 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Dizziness postural
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Dysgeusia
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Hypersomnia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Tension headache
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Disturbance in attention
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Restless legs syndrome
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Amnesia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Migraine
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Narcolepsy
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Paraesthesia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Parosmia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Sciatica
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Dry mouth
|
14.7%
22/150 • Number of events 22 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
9.8%
15/153 • Number of events 15 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Nausea
|
10.0%
15/150 • Number of events 15 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
11.1%
17/153 • Number of events 17 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Diarrhea
|
7.3%
11/150 • Number of events 11 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
9.2%
14/153 • Number of events 14 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Constipation
|
8.7%
13/150 • Number of events 13 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
4.6%
7/153 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.0%
3/153 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Toothache
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Feces discoloured
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Feces soft
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Gastrointestinal disorders
Uvulitis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Insomnia
|
6.7%
10/150 • Number of events 10 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
5.9%
9/153 • Number of events 9 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Anxiety
|
6.0%
9/150 • Number of events 9 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
4.6%
7/153 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Irritability
|
4.0%
6/150 • Number of events 6 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
6.5%
10/153 • Number of events 10 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Libido decreased
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
5.9%
9/153 • Number of events 9 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Restlessness
|
2.7%
4/150 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Abnormal dreams
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Bruxism
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Sleep disorder
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Suicidal ideation
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Anorgasmia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Nightmare
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Middle insomnia
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Orgasm abnormal
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Agitation
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Anger
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Derealisation
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Mental status changes
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Nervousness
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
7/150 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Bronchitis
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Sinusitis
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Influenza
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Viral infection
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Cellulitis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Ear infection
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Laryngitis
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Nasopharyngitis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Rhinitis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Tinea pedis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Tooth infection
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.3%
11/150 • Number of events 11 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
4.6%
7/153 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
3.3%
5/153 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
5/150 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.0%
3/153 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Infections and infestations
Pruritus
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.0%
3/153 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Renal and urinary disorders
Dysuria
|
3.3%
5/150 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Renal and urinary disorders
Urinary hesitation
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Renal and urinary disorders
Micturition urgency
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
3/150 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Palpitations
|
3.3%
5/150 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.6%
4/153 • Number of events 4 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.0%
3/153 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Bradycardia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Coronary artery dilatation
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Eye disorders
Vision blurred
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
4.6%
7/153 • Number of events 7 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Eye disorders
Dry eye
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Eye disorders
Blepharitis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Eye disorders
Blepharospasm
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Eye disorders
Eye pruritus
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Eye disorders
Periorbital edema
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
5/150 • Number of events 5 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
2.0%
3/153 • Number of events 3 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Ear and labyrinth disorders
Vertigo
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Vascular disorders
Hot flush
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Vascular disorders
Hypertension
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Vascular disorders
Flushing
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Cardiac disorders
Hypertensive crisis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Vascular disorders
Orthostatic hypotension
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.3%
2/150 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Reproductive system and breast disorders
Nocturnal emission
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
1.3%
2/153 • Number of events 2 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Investigations
Weight increased
|
0.00%
0/150 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.65%
1/153 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Investigations
White blood cell count increased
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
|
Endocrine disorders
Adrenal mass
|
0.67%
1/150 • Number of events 1 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
0.00%
0/153 • AEs were collected at all study visits screening to Week 8
Adverse Events were based on the "Safety Analysis Set: All randomized subjects who complete the (post-randomization) baseline appointment with the treating investigator, i.e., start AGT or TAU treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place