Trial Outcomes & Findings for Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease (NCT NCT02097056)
NCT ID: NCT02097056
Last Updated: 2016-06-27
Results Overview
Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
171 participants
Primary outcome timeframe
Baseline (Day 1) up to Week 24
Results posted on
2016-06-27
Participant Flow
Out of the 171 participants enrolled into the study, 1 was not treated resulting in 170 participants in the safety population.
Participant milestones
| Measure |
Donepezil Hydrochloride
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
171
|
|
Overall Study
ParticipantsTreated
|
170
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
| Measure |
Donepezil Hydrochloride
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
37
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Safety and Efficacy of Donepezil HCl 23 mg in Patients With Moderate to Severe Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Donepezil Hydrochloride
n=170 Participants
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Age, Continuous
|
74.82 Years
STANDARD_DEVIATION 7.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Week 24Population: Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.
Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.
Outcome measures
| Measure |
Donepezil Hydrochloride
n=170 Participants
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Overall Summary of Adverse Events (AEs)
AEs
|
67.65 Percentage of participants
|
|
Overall Summary of Adverse Events (AEs)
ADRs
|
47.06 Percentage of participants
|
|
Overall Summary of Adverse Events (AEs)
SAEs
|
7.06 Percentage of participants
|
|
Overall Summary of Adverse Events (AEs)
Serious ADRs
|
0.59 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24 (Final visit)Population: Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.
The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. The mean change was analyzed by Wilcoxon's signed rank test.
Outcome measures
| Measure |
Donepezil Hydrochloride
n=150 Participants
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Change W12
|
-0.31 Scores on a scale
Standard Deviation 2.76
|
|
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Change W24
|
-0.40 Scores on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24 (Follow up visit)Population: Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.
The NPI-Q assessed twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient's caregiver who was asked if the behavior described is present in the patient. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.
Outcome measures
| Measure |
Donepezil Hydrochloride
n=150 Participants
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores
Change Week 24 (Distress)
|
0.29 Scores on a scale
Standard Deviation 7.60
|
|
Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores
Change Week 12 (Severity)
|
0.33 Scores on a scale
Standard Deviation 4.74
|
|
Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores
Change Week 24 (Severity)
|
0.09 Scores on a scale
Standard Deviation 5.67
|
|
Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores
Change Week 12 (Distress)
|
0.19 Scores on a scale
Standard Deviation 6.83
|
Adverse Events
Donepezil Hydrochloride
Serious events: 12 serious events
Other events: 109 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Donepezil Hydrochloride
n=170 participants at risk
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Gait disturbance
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Infections and infestations
Pneumonia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
Other adverse events
| Measure |
Donepezil Hydrochloride
n=170 participants at risk
Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
12.4%
21/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Vomiting
|
11.2%
19/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
11/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Dizziness
|
7.6%
13/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Lethargy
|
4.7%
8/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.4%
16/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
5/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Headache
|
3.5%
6/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Somnolence
|
3.5%
6/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Constipation
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Gastrointestinal disorders
Dental caries
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Sedation
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Tremor
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Dreamy state
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Drooling
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Dysarthria
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Facial spasm
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Hypersomnia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Nervous system disorders
Paraesthesia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Anxiety
|
3.5%
6/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Insomnia
|
2.9%
5/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Aggression
|
2.4%
4/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Behavioural and psychiatric symptoms of dementia
|
1.8%
3/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Depression
|
1.8%
3/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Irritability
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Compulsions
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Compulsive hoarding
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Confusional state
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Delusion
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Depressed mood
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Disinhibition
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Nightmare
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Psychiatric disorders
Restlessness
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Electrocardiogram QT prolonged
|
2.9%
5/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Weight decreased
|
2.9%
5/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Blood glucose increased
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Glucose urine present
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Blood cholesterol increased
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Blood triglycerides increased
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Asthenia
|
2.4%
4/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Fatigue
|
1.8%
3/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Gait disturbance
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Chills
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Oedema
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
General disorders
Pain
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.5%
6/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Renal and urinary disorders
Enuresis
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Renal and urinary disorders
Incontinence
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Renal and urinary disorders
Nocturia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Renal and urinary disorders
Pollakiuria
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Infections and infestations
Periodontitis
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Infections and infestations
Pharyngitis
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Infections and infestations
Urinary tract infection
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Cardiac disorders
Atrioventricular block second degree
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Cardiac disorders
Bradycardia
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Vascular disorders
Hypertension
|
1.2%
2/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Vascular disorders
Pallor
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Eye disorders
Eye pain
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
|
Immune system disorders
Hypersensitivity
|
0.59%
1/170 • AEs were collected from Day 1 through Week 24 of study.
Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment. Summary and analysis of adverse events were analyzed using TEAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER