Trial Outcomes & Findings for Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (NCT NCT02446132)
NCT ID: NCT02446132
Last Updated: 2025-10-15
Results Overview
An adverse event (AE)is any untoward medical occurrence or unintended change (e.g. physical, psychological, or behavioral), including inter-current illness, whether considered related to treatment or not. An AE can therefore be any unfavorable and unintended sign (including any clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1197 participants
Primary outcome timeframe
From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Results posted on
2025-10-15
Participant Flow
Subjects took part in the study at 217 clinical sites in the North America and Europe from 13 November 2015 to 06 September 2024.
Of the 1197 subjects who were enrolled for the study, 1191 subjects received the study treatment, and 6 subjects did not receive the study drug. All eligible subjects received AVP-786-42.63/4.9, AVP-786-28/4.9, or AVP-786-18/4.9 depending on the last treatment received in the preceding study 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
Participant milestones
| Measure |
AVP-786 18 18 Milligrams (mg)
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks..
|
|---|---|---|---|
|
Overall Study
STARTED
|
166
|
517
|
514
|
|
Overall Study
COMPLETED
|
109
|
332
|
324
|
|
Overall Study
NOT COMPLETED
|
57
|
185
|
190
|
Reasons for withdrawal
| Measure |
AVP-786 18 18 Milligrams (mg)
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks..
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
27
|
27
|
|
Overall Study
Death
|
2
|
13
|
10
|
|
Overall Study
Lack of Efficacy
|
1
|
10
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
5
|
|
Overall Study
Non-compliance With Study Drug
|
2
|
2
|
3
|
|
Overall Study
Physician Decision
|
1
|
8
|
13
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
1
|
|
Overall Study
Study Subject Withdrawal by Parent or Guardian
|
14
|
36
|
22
|
|
Overall Study
Study Terminated by Sponsor
|
4
|
35
|
58
|
|
Overall Study
Trial Site Terminated by Sponsor
|
6
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
29
|
25
|
|
Overall Study
Reason not Specified
|
4
|
16
|
10
|
|
Overall Study
Enrolled Participants Who Did Not Receive Study Medications
|
0
|
1
|
5
|
Baseline Characteristics
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Baseline characteristics by cohort
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
Total
n=1191 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
75.6 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
75.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
75.1 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
286 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
676 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
515 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
151 Participants
n=5 Participants
|
473 Participants
n=7 Participants
|
476 Participants
n=5 Participants
|
1100 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
13 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
69 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
562 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
620 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)Population: Safety population included all participants who received the study treatment.
An adverse event (AE)is any untoward medical occurrence or unintended change (e.g. physical, psychological, or behavioral), including inter-current illness, whether considered related to treatment or not. An AE can therefore be any unfavorable and unintended sign (including any clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
Outcome measures
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
109 Participants
|
304 Participants
|
292 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)Population: Safety population included all participants who received the study treatment.
A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
Outcome measures
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Serious TEAE
|
22 Participants
|
75 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline (current study) up to 52 weeksPopulation: Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category.
Laboratory assessments included clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, cholesterol, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, protein, potassium, sodium, triglycerides and uric acid), hematology (basophils, eosinophils/leukocytes, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils/leukocytes, platelets). Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in statistical analysis plan (SAP). The categories with at least one participant with potentially clinically significant laboratory values are reported.
Outcome measures
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Erythrocytes (10^12/L): ≤2.5 x10^12/L
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Erythrocytes (10^12/L): ≥7.0 x10^12/L
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Hematocrit (%): <0.3 proportion of 1.0
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Hematocrit (%): >0.5 proportion of 1.0
|
11 Participants
|
31 Participants
|
44 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Hemoglobin (g/L): <100 g/L
|
5 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Hemoglobin (g/L): >180 g/L
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Leukocytes (10^9/L): ≤2.8 x10^9/L
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Leukocytes (10^9/L):≥16 x10^9/L
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Lymphocytes (10^9/L): ≤0.5 x10^9/L
|
0 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Lymphocytes (10^9/L): >4 x10^9/L
|
1 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Lymphocytes/Leukocytes (%): ≤10 %
|
6 Participants
|
30 Participants
|
21 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Lymphocytes/Leukocytes (%): ≥60 %
|
0 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Monocytes (10^9/L): >1 x10^9/L
|
7 Participants
|
27 Participants
|
23 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Monocytes/Leukocytes (%): ≥15 %
|
5 Participants
|
24 Participants
|
23 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Neutrophils/Leukocytes (%): ≤15 %
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Platelets (10^9/L): ≤100 x10^9/L
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Platelets (10^9/L): ≥700 x10^9/L
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Alanine Aminotransferase (units per litre {U/L}): ≥3X ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Albumin (grams per litre {g/L}): ≤26 g/L
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Albumin (g/L): ≥60 g/L
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Alkaline Phosphatase (U/L): ≥3X ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Aspartate Aminotransferase (U/L): ≥3X ULN
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Bilirubin (micromoles per liter {umol/L}): ≥1.5X ULN
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Blood Urea Nitrogen (millimoles per liter {mmol/L}): ≥10.71 mmol/L
|
19 Participants
|
78 Participants
|
63 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Carbon Dioxide (mmol/L): >40 mmol/L
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Calcium (mmol/L): ≤1.75 mmol/L
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Calcium (mmol/L): ≥3.0 mmol/L
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Cholesterol (mmol/L): ≥7.77 mmol/L
|
7 Participants
|
19 Participants
|
18 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Creatine Kinase (U/L): ≥3X ULN
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Creatinine (umol/L): >132.6 umol/L
|
8 Participants
|
53 Participants
|
26 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Gamma Glutamyl Transferase (U/L): ≥60 U/L
|
13 Participants
|
52 Participants
|
51 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Glucose (mmol/L): ≤2.775 mmol/L
|
3 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Glucose (mmol/L): ≥11.1 mmol/L
|
22 Participants
|
71 Participants
|
79 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Lactate Dehydrogenase (U/L): ≥3X ULN
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Magnesium (mmol/L): <0.37 mmol/L
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Magnesium (mmol/L): >1.23 mmol/L
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Potassium (mmol/L): ≤3.0 mmol/L
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Potassium (mmol/L): ≥5.5 mmol/L
|
6 Participants
|
32 Participants
|
34 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Protein (g/L): ≤50 g/L
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Sodium (mmol/L): ≤130 mmol/L
|
6 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Sodium (mmol/L): ≥155 mmol/L
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Triglycerides (mmol/L): >3.39 mmol/L
|
25 Participants
|
61 Participants
|
73 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Uric Acid (umol/L) (Female): ≥505.58 umol/L
|
3 Participants
|
22 Participants
|
14 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Uric Acid (umol/L) (Male): ≥624.54 umol/L
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Basophils (10^9/L): >0.3 x10^9/L
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Eosinophils/Leukocytes (%): ≥10 %
|
12 Participants
|
23 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Baseline (current study) up to 52 weeksPopulation: Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category.
A resting 12-lead ECG was performed for all the participants. ECG data included PR interval (milliseconds {msec}) and QTcF (msec) along with change from baseline in QTcF. Number of participants with potentially clinically significant ECG abnormalities was reported as per the criteria defined in SAP.
Outcome measures
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
PR Interval Value (males and females): >200 to ≤220 msec
|
21 Participants
|
66 Participants
|
60 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
PR Interval Value (males and females): >220 to ≤250 msec
|
13 Participants
|
33 Participants
|
28 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
PR Interval Value (males and females): >250 msec
|
5 Participants
|
13 Participants
|
9 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Value (males): >450 to ≤480 msec
|
9 Participants
|
28 Participants
|
23 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Value (males): >480 to ≤500 msec
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Value (females): >470 to ≤485 msec
|
3 Participants
|
12 Participants
|
10 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Value (females): >485 to ≤500 msec
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Value (females): >500 msec
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Change from Baseline (male and females): ≥30 msec
|
18 Participants
|
64 Participants
|
66 Participants
|
|
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
QTcF Change from Baseline (male and females): ≥60 msec
|
1 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline (current study), Week 52Population: Safety population included all participants who received the study treatment.
The physical examination included assessments of head, eyes, ears, nose, throat, lymph nodes, skin, extremities, respiratory, gastrointestinal, musculoskeletal, cardiovascular, and nervous systems. The neurological examination included assessments of mental status, cranial nerves, motor system, reflexes, coordination, gait and station, and sensory system.
Outcome measures
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding
|
2 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline (current study) up to 52 weeksPopulation: Safety population included all participants who received the study treatment. 'Overall number analyzed' indicates the unique participants who were evaluated for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specific category.
Vital signs measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and standing positions after the participant had been in each position for at least 5 and 3 minutes, respectively. Number of participants with clinically significant vital sign abnormalities were reported as per criteria defined in SAP. The categories with at least one participant with clinically significant vital signs abnormalities are reported here.
Outcome measures
| Measure |
AVP-786 18 mg
n=166 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
SBP: ≤90 and ≥20 decrease from baseline
|
5 Participants
|
18 Participants
|
14 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
SBP: >180 and ≥20 increase from baseline
|
0 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
DBP: ≤50 and ≥15 decrease from baseline
|
4 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
DBP: ≥105 and ≥15 increase from baseline
|
2 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
HR: ≤50 and ≥15 decrease from baseline
|
0 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
HR: ≥120 and ≥15 increase from baseline
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
SBP ≥10 and HR ≥5 increase from baseline
|
53 Participants
|
147 Participants
|
155 Participants
|
|
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
DBP ≥5 and HR ≥5 increase from baseline
|
61 Participants
|
239 Participants
|
225 Participants
|
PRIMARY outcome
Timeframe: Baseline (current study), Week 64Population: Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point.
The S-STS is a prospective scale that assesses treatment-emergent suicidal thoughts and behaviors. This is a 20-item scale where each item (except item 17) of the S-STS is scored on a 5-point Likert scale as: 0 = Not at all, 1 = A little, 2 = Moderate, 3 = Very, 4 = Extremely. The S-STS total score is calculated by the sum of items 1a (if present), items 2-11, highest score of item 12 or 16, highest score of item 14 or 15, item 17 and 20. The total score ranges from 0 to 156 (If response to S-STS item 17 =yes, a score of 100 was added to the S-STS total score). Higher scores indicate greater severity of suicidal ideation and/or behavior. A negative change from baseline reflects a reduction in suicidal thoughts or behaviors over time.
Outcome measures
| Measure |
AVP-786 18 mg
n=92 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=276 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=304 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64
|
-0.0 score on a scale
Standard Deviation 0.1
|
0.0 score on a scale
Standard Deviation 0.1
|
-0.0 score on a scale
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: Baseline (current study), Week 52Population: Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point.
The MMSE is a brief questionnaire that is used to assess cognitive impairment and severity of cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate a participant's cognitive state and are scored as follows: Orientation to Time - 0 to 5; Orientation to Place - 0 to 5; Registration - 0 to 3; Attention and Calculation - 0 to 5; Recall - 0 to 3; Naming - 0 to 2; Repetition - 0 to 1; Comprehension - 0 to 3; Reading - 0 to 1; Writing - 0 to 1; Drawing - 0 to 1. The total score was calculated by summing all of the item scores and ranges from 0 to 30. Higher scores indicate milder cognitive impairment. Negative change from baseline indicates decline in cognitive performance.
Outcome measures
| Measure |
AVP-786 18 mg
n=121 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=372 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=366 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52
|
-0.8 score on a scale
Standard Deviation 4.6
|
-0.7 score on a scale
Standard Deviation 4.9
|
-0.1 score on a scale
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Baseline (current study), Week 52Population: Safety population included all participants who received the study treatment. 'Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure at the specified time point.
The ESS is an 8-item questionnaire that is used to measure sleepiness by rating the probability of falling asleep on 8 different situations that most people engage in during the day. The 8 questions are rated on a 4-point scale (0 to 3) where 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. The scores are summed to give an overall score of 0 to 24. A total score of 0 to 9 is considered to be normal. Higher score indicates greater daytime sleepiness. Negative change from baseline indicate improvement in daytime sleepiness.
Outcome measures
| Measure |
AVP-786 18 mg
n=83 Participants
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=297 Participants
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=338 Participants
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52
|
-0.01 score on a scale
Standard Deviation 4.43
|
0.07 score on a scale
Standard Deviation 4.39
|
0.50 score on a scale
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: Baseline (current study), Week 64Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The CMAI is used to assess the frequency of manifestations of agitated behaviors in elderly persons. It consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. These distinct agitation syndromes include aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Each of the 29 items is rated on a 7-point scale of frequency (1 = never, 2 = less than once a week but still occurring, 3 = once or twice a week, 4 = several times a week, 5 = once or twice a day, 6 = several times a day, 7 = several times an hour). The ratings are based on the 2 weeks preceding assessment of the CMAI. Higher scores indicate higher frequency of agitated behaviours while lower scores indicate lower frequency of agitated behaviours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 52Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The NPI is a validated clinical instrument used to assess neuropsychiatric symptoms. It evaluates 12 neuropsychiatric symptom domains including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavioral disorders, and appetite/eating disorders. Each symptom domain is rated by the caregiver based on the frequency (1 to 4) and severity (1 to 3) of symptoms, and a composite domain score is calculated by multiplying frequency and severity (range: 1-12). Additionally, caregiver distress for each positive symptom domain is rated on a 6-point scale (0 = not at all distressing, 5 = extremely distressing). In this study, the three NPI domains assessed were agitation/aggression, irritability/lability, and aberrant motor behavior. Higher scores indicate greater severity and frequency of neuropsychiatric symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 64Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The mADCS-CGIC-Agitation is used to assess agitation in individuals with Alzheimer's disease. It includes questions focused on agitation and uses a semi-structured interview format involving both the participant and their caregiver. The clinician rates the participant's overall clinical status using a 7-point scale: 1 = marked improvement, 2 = moderate improvement, 3 = minimal improvement, 4 = no change, 5 = minimal worsening, 6 = moderate worsening, and 7 = marked worsening. Lower scores indicate improvement in agitation symptoms, while higher scores indicate worsening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 52Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The CGIS is an observer-rated scale that measures illness severity. The CGIS-Agitation is a 7-point (1-7) scale (1 = normal, not at all ill; 7 = extremely ill) that assessed the severity of agitation in this study. Higher scores indicate severe agitation, while the lower scores indicate little or no agitation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 52Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The PGIC is a 7-point scale used to assess perceived treatment response, as evaluated by the participant's caregiver. The caregiver rates the overall change in the participant's condition since the start of treatment. The PGIC score ranges from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores reflect greater improvement, while higher scores indicate worsening of the participant's condition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 52Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The DEMQOL is a validated scale used to assess health-related quality of life in individuals with dementia and their caregivers. It includes two versions: a 28-item version completed by the participant (DEMQOL), and a 31-item proxy version completed by the caregiver (DEMQOL-proxy). Each item is rated using a 4-point scale to reflect the frequency or severity of health-related concerns: 1 = A lot, 2 = Quite a bit, 3 = A little, 4 = Not at all. Total score is derived by sum of all item scores, excluding item 29 of DEMQOL and item 32 of DEMQOL-proxy. Lower scores indicate better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 52Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The RUD is a standardized tool used to estimate healthcare costs associated with dementia. It assesses the use of both formal and informal (e.g., hospitalizations, doctor visits, living assistance, and unprofessional caregiver time) healthcare resources. The instrument is administered as a semi-structured interview with the participant's primary caregiver. It consists of two main sections: one evaluates the caregiver's burden, including lost work and leisure time, and the other documents the participant's use of healthcare services. Total healthcare costs are calculated by multiplying the quantity of resources used (e.g., number of doctor visits, hours of caregiver, nights in accommodation) by unit costs. Higher estimated totals reflect greater economic impact associated with dementia care.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (current study), Week 52Population: Due to discontinuation of development of the AVP-786 compound, no data was collected and analyzed as planned for this pre-specified secondary efficacy outcome measure as noted in the SAP. Only safety data was collected and analyzed.
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life. It consists of two components: a descriptive system and the EuroQol Visual Analogue Scale (EQ VAS). The descriptive system covers five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale: 1 = No problems, 2 = Slight problems, 3 = Moderate problems, 4 = Severe problems, 5 = Extreme problems. The EQ VAS component allows participants or caregivers to rate the individual's overall health on a vertical scale from 0 (the worst imaginable health state) to 100 (the best imaginable health state). Only participants from Study 17-AVP-786-305 with a MMSE score of 10 or higher at the baseline visit were planned to complete the participant-rated version.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (current study) up to 64 weeksConcomitant medications were defined as any medications taken on or after the date of first dose of study drug in Study 15-AVP-786-303 or that are ongoing concomitant medications from Studies 15-AVP-786-301, 15-AVP-786-302, 17-AVP-786-305, and 12-AVR-131.
Outcome measures
Outcome data not reported
Adverse Events
AVP-786 18 mg
Serious events: 22 serious events
Other events: 54 other events
Deaths: 4 deaths
AVP-786 28 mg
Serious events: 75 serious events
Other events: 150 other events
Deaths: 22 deaths
AVP-786 42.63 mg
Serious events: 70 serious events
Other events: 149 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
AVP-786 18 mg
n=166 participants at risk
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 participants at risk
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 participants at risk
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Eye disorders
Keratitis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.58%
3/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
General disorders
Death
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
General disorders
Disease progression
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
General disorders
Inflammation
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.97%
5/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
1.4%
7/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Pneumonia
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.58%
3/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
1.6%
8/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Cystitis
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Sepsis
|
1.2%
2/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Pyuria
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Septic shock
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
2/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
2.3%
12/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.98%
5/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.58%
3/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.59%
3/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.78%
4/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Intentional medical device removal by patient
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Investigations
Blood glucose increased
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Investigations
Blood osmolarity increased
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Investigations
Troponin increased
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.97%
5/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Syncope
|
1.8%
3/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.78%
4/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.79%
4/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.58%
3/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Basal ganglia haematoma
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Dementia
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Dysstasia
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Agitation
|
2.4%
4/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
1.2%
6/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.79%
4/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.79%
4/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Aggression
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Disturbance in social behaviour
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.79%
4/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Hypertension
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.39%
2/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.60%
1/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.20%
1/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.19%
1/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
0.00%
0/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
Other adverse events
| Measure |
AVP-786 18 mg
n=166 participants at risk
Participants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 28 mg
n=516 participants at risk
Participants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
|
AVP-786 42.63 mg
n=509 participants at risk
Participants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
10/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
5.4%
28/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
5.1%
26/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
13/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
8.7%
45/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
8.4%
43/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.0%
10/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
3.1%
16/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
2.2%
11/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
16.3%
27/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
15.3%
79/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
11.8%
60/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Nervous system disorders
Headache
|
6.0%
10/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
2.7%
14/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
3.3%
17/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
|
Psychiatric disorders
Agitation
|
6.0%
10/166 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
6.2%
32/516 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
7.7%
39/509 • From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Safety population included all subjects who received the study treatment.
|
Additional Information
Clinical Transparency
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 08446878522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place