Trial Outcomes & Findings for Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study (NCT NCT02585934)
NCT ID: NCT02585934
Last Updated: 2018-12-05
Results Overview
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1315 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2018-12-05
Participant Flow
2173 participants signed consent and were screened for participation. Of these, 1470 entered a 3-week single-blind placebo run-in period with treatment with placebo qd + stable dose of donepezil 5 or 10 mg qd. There was an overlap between the participants from the run-in period and the participants that were randomized during the treatment period.
Participant milestones
| Measure |
RVT-101
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks
|
Placebo
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
661
|
654
|
|
Overall Study
Safety Population
|
656
|
651
|
|
Overall Study
Intent to Treat (ITT)
|
643
|
633
|
|
Overall Study
Per Protocol (PP)
|
603
|
582
|
|
Overall Study
COMPLETED
|
592
|
581
|
|
Overall Study
NOT COMPLETED
|
69
|
73
|
Reasons for withdrawal
| Measure |
RVT-101
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks
|
Placebo
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
14
|
11
|
|
Overall Study
Adverse Event
|
21
|
22
|
|
Overall Study
Physician Decision
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
21
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Caregiver Withdrew Consent
|
7
|
7
|
|
Overall Study
Sponsor Termination
|
1
|
2
|
|
Overall Study
Another Reason
|
10
|
5
|
Baseline Characteristics
Data was missing for one subject
Baseline characteristics by cohort
| Measure |
RVT-101
n=643 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks
|
Placebo
n=633 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks
|
Total
n=1276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.7 years
n=643 Participants
|
72.5 years
n=633 Participants
|
72.6 years
n=1276 Participants
|
|
Age, Customized
< 74 years
|
309 Participants
n=643 Participants
|
312 Participants
n=633 Participants
|
621 Participants
n=1276 Participants
|
|
Age, Customized
>/= 74 years
|
334 Participants
n=643 Participants
|
321 Participants
n=633 Participants
|
655 Participants
n=1276 Participants
|
|
Age, Customized
< 65 years
|
98 Participants
n=643 Participants
|
97 Participants
n=633 Participants
|
195 Participants
n=1276 Participants
|
|
Age, Customized
>/=65 years
|
545 Participants
n=643 Participants
|
536 Participants
n=633 Participants
|
1081 Participants
n=1276 Participants
|
|
Sex: Female, Male
Female
|
386 Participants
n=643 Participants
|
394 Participants
n=633 Participants
|
780 Participants
n=1276 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=643 Participants
|
239 Participants
n=633 Participants
|
496 Participants
n=1276 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
120 Participants
n=643 Participants
|
108 Participants
n=633 Participants
|
228 Participants
n=1276 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
518 Participants
n=643 Participants
|
519 Participants
n=633 Participants
|
1037 Participants
n=1276 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=643 Participants
|
6 Participants
n=633 Participants
|
11 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
595 Participants
n=643 Participants
|
592 Participants
n=633 Participants
|
1187 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
12 Participants
n=643 Participants
|
10 Participants
n=633 Participants
|
22 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
27 Participants
n=643 Participants
|
20 Participants
n=633 Participants
|
47 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=643 Participants
|
0 Participants
n=633 Participants
|
0 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=643 Participants
|
1 Participants
n=633 Participants
|
1 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · Others
|
2 Participants
n=643 Participants
|
1 Participants
n=633 Participants
|
3 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · Not Applicable
|
3 Participants
n=643 Participants
|
5 Participants
n=633 Participants
|
8 Participants
n=1276 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
4 Participants
n=643 Participants
|
4 Participants
n=633 Participants
|
8 Participants
n=1276 Participants
|
|
BMI
|
26.4 kg/m^2
n=642 Participants • Data was missing for one subject
|
26.5 kg/m^2
n=633 Participants • Data was missing for one subject
|
26.4 kg/m^2
n=1275 Participants • Data was missing for one subject
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT Population with data at both timepoints.
The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
Outcome measures
| Measure |
RVT-101
n=584 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
n=577 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
|
0.39 units on a scale
Standard Error 0.211
|
0.75 units on a scale
Standard Error 0.213
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT Population with data at both endpoints
The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function
Outcome measures
| Measure |
RVT-101
n=588 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
n=575 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24
|
-1.06 units on a scale
Standard Error 0.289
|
-0.97 units on a scale
Standard Error 0.293
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: ITT population at the Week 24 timepoint
The CIBIC+ assessment measures the global functioning of the subject. The CIBIC+ is scored as a seven-point categorical rating, ranging from a score of 1 (indicating "very much improved"), to a score of 4 (indicating "no change"), or to a score of 7 (indicating "very much worse.") Lower CIBIC+ scores indicate better (more desirable) function
Outcome measures
| Measure |
RVT-101
n=577 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
n=568 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24
|
4.18 units on a scale
Standard Error 0.037
|
4.30 units on a scale
Standard Error 0.037
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT population at both timepoints
The DS measures the amount of assistance patients with dementia require in performing daily activities. The scale consists of 13 items, representing a range of severity from mild to severe levels of dependency. The score range is from 0 to 15 with higher scores indicating greater dependency.
Outcome measures
| Measure |
RVT-101
n=580 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
n=568 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
The Dependence Scale (DS) Score Change From Baseline to Week 24
|
0.30 units on a scale
Standard Error 0.070
|
0.17 units on a scale
Standard Error 0.071
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT Population at both timepoints
The NPI is a behavior rating scale composed of a 12-item structured interview of the caregiver that is scored from 0 to 144 (the higher the score, the greater the psychiatric disturbance). It assesses 12 behavioral disturbances occurring in dementia patients: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor activity, night-time behavior disturbances, and eating disturbances. Both the frequency and the severity of each behavior are determined.
Outcome measures
| Measure |
RVT-101
n=583 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
n=570 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24
|
-0.08 units on a scale
Standard Error 0.339
|
0.06 units on a scale
Standard Error 0.344
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: ITT at both timepoints
13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.
Outcome measures
| Measure |
RVT-101
n=583 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
n=576 Participants
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
ADAS-Cog-13 Score Change From Baseline to Week 24
|
0.26 units on a scale
Standard Error 0.233
|
0.64 units on a scale
Standard Error 0.236
|
SECONDARY outcome
Timeframe: Week 6, Week 12, Week 18, Week 24Population: PK population at specified timepoints: Week 6, Week 12, Week 18, and Week 24
Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24
Outcome measures
| Measure |
RVT-101
n=656 Participants
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets
|
Placebo
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet
|
|---|---|---|
|
Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
Summary Statistics at Week 6
|
201.11 ng/mL
Interval 191.88 to 210.78
|
—
|
|
Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
Summary Statistics at Week 12
|
170.95 ng/mL
Interval 164.4 to 177.76
|
—
|
|
Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
Summary Statistics at Week 18
|
198.69 ng/mL
Interval 189.36 to 208.48
|
—
|
|
Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
Summary Statistics at Week 24
|
193.36 ng/mL
Interval 184.6 to 202.53
|
—
|
Adverse Events
RVT-101 Treatment
Serious events: 40 serious events
Other events: 191 other events
Deaths: 3 deaths
Placebo Treatment
Serious events: 44 serious events
Other events: 166 other events
Deaths: 2 deaths
Screening Period
Serious events: 12 serious events
Other events: 0 other events
Deaths: 1 deaths
Run-In Period
Serious events: 14 serious events
Other events: 0 other events
Deaths: 1 deaths
RVT-101 Post-Treatment
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Post-Treatment
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
RVT-101 Treatment
n=656 participants at risk
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks
|
Placebo Treatment
n=651 participants at risk
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks
|
Screening Period
n=2173 participants at risk
Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period)
|
Run-In Period
n=1470 participants at risk
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 3 weeks)
|
RVT-101 Post-Treatment
n=656 participants at risk
Subjects reported adverse events after completing the treatment period.
The Post-Treatment period - defined as up to 30 days post-last-dose
|
Placebo Post-Treatment
n=651 participants at risk
Subjects reported adverse events after completing the treatment period.
The Post-Treatment period - defined as up to 30 days post-last-dose
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.46%
3/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Syncope
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Ischaemic stroke
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Seizure
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.31%
2/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Dementia
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Headache
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Lethargy
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.46%
3/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.20%
3/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Myocardial infarction
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.31%
2/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Pericardial effusion
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Right ventricular failure
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Diverticulitis
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.31%
2/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Pneumonia
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Urinary tract infection
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Appendicitis
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Cellulitis
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.46%
3/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.46%
3/651 • Screening through post treatment (up to 33 weeks)
|
0.09%
2/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Stoma obstruction
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Duodenal vascular ectasia
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Proctitis
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Aggression
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Delirium
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
2/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
|
General disorders
Chest pain
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
General disorders
Hypothermia
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Ear and labyrinth disorders
Vertigo positonal
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Vascular disorders
Hypertension
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Vascular disorders
Poor peripheral circulation
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Investigations
Haemoglobin decreased
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.05%
1/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
lower respiratory tract infection
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Infected bite
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
General disorders
Asthenia
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.07%
1/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
General disorders
Gait disturbance
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Sepsis
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
|
Reproductive system and breast disorders
invasive ductal breast carcinoma
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.15%
1/651 • Screening through post treatment (up to 33 weeks)
|
Other adverse events
| Measure |
RVT-101 Treatment
n=656 participants at risk
RVT-101 adjunct to 5 mg or 10 mg donepezil
RVT-101: once daily, oral, 35 mg tablets for up to 27 weeks
|
Placebo Treatment
n=651 participants at risk
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks
|
Screening Period
n=2173 participants at risk
Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period)
|
Run-In Period
n=1470 participants at risk
Placebo adjunct to 5 mg or 10 mg donepezil
Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 3 weeks)
|
RVT-101 Post-Treatment
n=656 participants at risk
Subjects reported adverse events after completing the treatment period.
The Post-Treatment period - defined as up to 30 days post-last-dose
|
Placebo Post-Treatment
n=651 participants at risk
Subjects reported adverse events after completing the treatment period.
The Post-Treatment period - defined as up to 30 days post-last-dose
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
37/656 • Screening through post treatment (up to 33 weeks)
|
4.5%
29/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Infections and infestations
Urinary tract infection
|
3.8%
25/656 • Screening through post treatment (up to 33 weeks)
|
4.0%
26/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
3.5%
23/656 • Screening through post treatment (up to 33 weeks)
|
2.9%
19/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Headache
|
2.6%
17/656 • Screening through post treatment (up to 33 weeks)
|
2.8%
18/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Nervous system disorders
Dizziness
|
2.9%
19/656 • Screening through post treatment (up to 33 weeks)
|
1.8%
12/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
13/656 • Screening through post treatment (up to 33 weeks)
|
2.6%
17/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Gastrointestinal disorders
Nausea
|
2.6%
17/656 • Screening through post treatment (up to 33 weeks)
|
2.0%
13/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
11/656 • Screening through post treatment (up to 33 weeks)
|
2.3%
15/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.1%
14/656 • Screening through post treatment (up to 33 weeks)
|
1.5%
10/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
15/656 • Screening through post treatment (up to 33 weeks)
|
1.1%
7/651 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/2173 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/1470 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/656 • Screening through post treatment (up to 33 weeks)
|
0.00%
0/651 • Screening through post treatment (up to 33 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All proposed manuscripts, publications or abstracts must be reviewed and approved by the Sponsor 60 days prior to submission for publication. All confidential information identified by the Sponsor must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER