Trial Outcomes & Findings for Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment (NCT NCT03446001)
NCT ID: NCT03446001
Last Updated: 2025-09-04
Results Overview
This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
598 participants
Primary outcome timeframe
52 weeks
Results posted on
2025-09-04
Participant Flow
Participant milestones
| Measure |
Control
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily during the double-blind phase, then switched to TRx0237 16 mg/day during the open-label phase
|
TRx0237 8 mg/Day
TRx0237 8 mg/day: Oral TRx0237 4-mg tablet administered twice daily during the double-blind phase, then switched to TRx0237 16 mg/day during the open-label phase
|
TRx0237 16 mg/Day
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily during the double-blind phase, continued on TRx0237 16 mg/day during the open-label phase
|
|---|---|---|---|
|
Double-blind Phase
STARTED
|
266
|
80
|
252
|
|
Double-blind Phase
COMPLETED
|
215
|
61
|
194
|
|
Double-blind Phase
NOT COMPLETED
|
51
|
19
|
58
|
|
Open-label Phase (All TRx0237 16 mg/Day)
STARTED
|
205
|
57
|
194
|
|
Open-label Phase (All TRx0237 16 mg/Day)
COMPLETED
|
176
|
47
|
168
|
|
Open-label Phase (All TRx0237 16 mg/Day)
NOT COMPLETED
|
29
|
10
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment
Baseline characteristics by cohort
| Measure |
Control
n=266 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 8 mg/Day
n=80 Participants
TRx0237 8 mg/day: Oral TRx0237 4-mg tablet administered twice daily
|
TRx0237 16 mg/Day
n=252 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
71.8 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
71.9 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
72.1 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
363 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
235 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
239 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
527 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
46 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADAS-cog11 as a covariate).
This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment).
Outcome measures
| Measure |
Control
n=198 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=189 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (16 mg/Day vs Control)
|
1.71 score on a scale
Interval 0.69 to 2.73
|
1.34 score on a scale
Interval 0.32 to 2.36
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADCS-ADL23 as a covariate).
This primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment).
Outcome measures
| Measure |
Control
n=204 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=191 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (16 mg/Day vs Control)
|
-0.77 score on a scale
Interval -2.32 to 0.78
|
-0.62 score on a scale
Interval -2.19 to 0.95
|
PRIMARY outcome
Timeframe: 52 weeksThis primary outcome measure was assessed in the TRx0237 16 mg/day group compared to the placebo group. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator are to be reported as adverse events.
Outcome measures
| Measure |
Control
n=266 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=252 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Number of Study Participants With Serious and Non-serious Adverse Events (16 mg/Day vs Control)
Number of study participants with serious adverse events
|
17 Participants
|
18 Participants
|
|
Number of Study Participants With Serious and Non-serious Adverse Events (16 mg/Day vs Control)
Number of study participants with non-serious adverse events
|
146 Participants
|
131 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the MI-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline MRI assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline MRI whole brain volume as a covariate).
This secondary outcome measure was assessed in the TRx0237 16 mg/day group compared to the control group.
Outcome measures
| Measure |
Control
n=175 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=165 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change in Annualized Rate of Whole Brain Atrophy (16 mg/Day vs Control)
|
-11137.44 mm3/year
Interval -12682.86 to -9592.01
|
-11162.70 mm3/year
Interval -12711.43 to -9613.98
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the PI-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline 18F-FDG-PET SUVR assessment; results reported for subjects with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (ANCOVA with fixed effects, including Baseline PET temporal lobe glucose uptake as a covariate).
This secondary outcome measure (normalized to pons) was assessed in the TRx0237 16 mg/day dose group compared to the control group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening.
Outcome measures
| Measure |
Control
n=88 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=93 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change in Standardized Uptake Value Ratio (SUVR) Based on Temporal Lobe 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG-PET) (16 mg/Day vs Control)
|
-0.025 ratio
Interval -0.036 to -0.015
|
-0.026 ratio
Interval -0.036 to -0.016
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the MI-MITTv5 Population (all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline MRI assessment); results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline MRI whole temporoparietal lobe volume as a covariate).
This secondary outcome measure was assessed in the TRx0237 16mg/day group compared to the control group.
Outcome measures
| Measure |
Control
n=175 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=165 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change in Annualized Rate of Temporoparietal Lobe Atrophy (16 mg/Day vs Control)
|
-740.79 mm3/year
Interval -821.39 to -660.19
|
-711.14 mm3/year
Interval -791.96 to -630.32
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADAS-cog11 as a covariate).
This secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment). Note: Estimates for the Control Arm in the primary outcome and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Outcome measures
| Measure |
Control
n=198 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=47 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change From Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11) (8 mg/Day vs Control)
|
1.78 score on a scale
Interval 0.79 to 2.77
|
1.06 score on a scale
Interval -0.89 to 3.01
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the E-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline efficacy assessment; results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline ADCS-ADL23 as a covariate).
This secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group. The scores on this scale range from 0 to 78, with higher numbers indicating a better outcome (lower impairment). Note: Estimates for the Control Arm in the primary outcome and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Outcome measures
| Measure |
Control
n=204 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=47 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change From Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) (8 mg/Day vs Control)
|
-0.82 score on a scale
Interval -2.36 to 0.72
|
-1.41 score on a scale
Interval -4.46 to 1.64
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the PI-MITTv5 Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline 18F-FDG-PET SUVR assessment; results reported for subjects with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (ANCOVA with fixed effects, including Baseline PET temporal lobe glucose uptake as a covariate).
This secondary outcome measure was assessed in the TRx0237 8mg/day dose group compared to the control group, and restricted to subjects with Clinical Dementia Rating (CDR) 0.5 at Screening. Note: Estimates for the Control Arm in the TRx0237 16 mg/day dose group comparison and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Outcome measures
| Measure |
Control
n=88 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=22 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change in Standardized Uptake Value Ratio (SUVR) Based on Temporal Lobe 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG-PET) (8 mg/Day vs Control)
|
-0.027 ratio
Interval -0.038 to -0.016
|
-0.022 ratio
Interval -0.041 to -0.002
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Data analyzed using the MI-MITTv5 Population (all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug and have a Baseline and at least one valid postbaseline MRI assessment); results reported for subjects in this population with Baseline and Week 52 data. Change from Baseline to Week 52 is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline MRI whole temporoparietal volume as a covariate).
This secondary outcome measure was assessed in the TRx0237 8 mg/day dose group compared to the control group. Note: Estimates for the Control Arm in the TRx0237 16 mg/day dose group comparison and this secondary outcome are estimated using separate Mixed Models for Repeated Measures (MMRM). Thus, it is appropriate for the two models to yield two slightly different estimates for the Control Arm change as the comparator is different in each case and the model uses this information to make its estimates.
Outcome measures
| Measure |
Control
n=175 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=45 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change in Annualized Rate of Temporoparietal Lobe Atrophy (8 mg/Day vs Control)
|
-729.55 mm3/year
Interval -806.0 to -652.09
|
-651.28 mm3/year
Interval -799.33 to -503.24
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Data analyzed using the ITTv5-OL Population, which includes all subjects randomized to Protocol Version 5.0+ who received at least one dose of study drug in the open-label (OL) phase; results reported for subjects in this population with a Baseline-OL value and Week 104 data (52 weeks of OL drug). Change from Baseline-OL to Week 104 (52 weeks) is included in the LSM calculation (restricted maximum likelihood-based MMRM with fixed effects, including Baseline-OL ADAS-cog11 as a covariate).
This secondary outcome measure was assessed for the open-label period of the study comparing subjects originally randomized to placebo to subjects originally randomized to either dose of TRx0237. The scores on this scale range from 0 to 70, with higher numbers indicating a worse outcome (greater impairment). Note: It was prespecified to combine subjects who received TRx0237 8 mg/day or TRx0237 16 mg/day in the double-blind phase as early starters; thus these are combined for this comparison.
Outcome measures
| Measure |
Control
n=146 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=179 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Change From Open-Label Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11)
|
2.98 score on a scale
Interval 2.01 to 3.95
|
3.58 score on a scale
Interval 2.7 to 4.47
|
SECONDARY outcome
Timeframe: 52 weeksThis secondary outcome measure was assessed in the TRx0237 8 mg/day group compared to the control group over 52 weeks. All laboratory test or vital sign parameter abnormalities deemed clinically significant by the Investigator were to be reported as adverse events.
Outcome measures
| Measure |
Control
n=266 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=80 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Number of Study Participants With Serious and Non-serious Adverse Events (8 mg/Day vs Control)
Number of study participants with serious adverse events
|
17 Participants
|
6 Participants
|
|
Number of Study Participants With Serious and Non-serious Adverse Events (8 mg/Day vs Control)
Number of study participants with nonserious adverse events
|
146 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: A total of 7 subjects had discontinued study drug in the double-blind phase but completed this phase and continued to attend study visits in the open-label (OL) phase off-treatment. As these subjects did not receive TRX0237 16 mg/day in the OL phase, they are not included in the OL-Safety Population (N=449) and thus are not included in these comparisons.
This secondary outcome measure was assessed for all subjects receiving TRx0237 in the open-label phase of the study (in which subjects had received TRx0237 for up to 104 weeks). Note: Subjects who received TRx0237 8 mg/day or TRx0237 16 mg/day arms in the double-blind phase are combined for this comparison as all had previously received TRx0237 as compared to those subjects in the control arm who were receiving TRx0237 for the first time in the open-label phase.
Outcome measures
| Measure |
Control
n=201 Participants
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
TRx0237 16 mg/Day
n=248 Participants
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily
|
|---|---|---|
|
Number of Study Participants With Serious and Non-serious Adverse Events (Open-label)
Number of study participants with serious adverse events
|
14 Participants
|
13 Participants
|
|
Number of Study Participants With Serious and Non-serious Adverse Events (Open-label)
Number of study participants with nonserious adverse events
|
88 Participants
|
101 Participants
|
Adverse Events
Double-blind Control
Serious events: 17 serious events
Other events: 30 other events
Deaths: 1 deaths
Double-blind TRx0237 8 mg/Day
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Double-blind TRx0237 16 mg/Day
Serious events: 18 serious events
Other events: 22 other events
Deaths: 1 deaths
Open-label TRx0237 16 mg/Day
Serious events: 27 serious events
Other events: 40 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Double-blind Control
n=266 participants at risk
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
Double-blind TRx0237 8 mg/Day
n=80 participants at risk
TRx0237 8 mg/day: Oral TRx0237 4-mg tablet administered twice daily
|
Double-blind TRx0237 16 mg/Day
n=252 participants at risk
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily in the double-blind phase
|
Open-label TRx0237 16 mg/Day
n=449 participants at risk
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily in the open-label phase (all subjects who completed the double-blind phase and entered the open-label phase transitioned to receive this treatment)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
1.2%
1/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Eye disorders
Lens discolouration
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Eye disorders
Vision blurred
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Diverticulum
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.75%
2/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
1.2%
1/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.45%
2/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
1.2%
1/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
General disorders
Gait inability
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
General disorders
General physical health deterioration
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.79%
2/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.79%
2/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
1.2%
1/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Sepsis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Costal cartilage fracture
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
1.2%
1/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
1.2%
1/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Parkinsonism
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Presyncope
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Seizure
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Syncope
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Psychiatric disorders
Agitation
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.45%
2/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Renal and urinary disorders
Bladder disorder
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Renal and urinary disorders
Haematuria
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.38%
1/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
2.5%
2/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.40%
1/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.00%
0/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
0.22%
1/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
Other adverse events
| Measure |
Double-blind Control
n=266 participants at risk
Control: Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
|
Double-blind TRx0237 8 mg/Day
n=80 participants at risk
TRx0237 8 mg/day: Oral TRx0237 4-mg tablet administered twice daily
|
Double-blind TRx0237 16 mg/Day
n=252 participants at risk
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily in the double-blind phase
|
Open-label TRx0237 16 mg/Day
n=449 participants at risk
TRx0237 16 mg/day: Oral TRx0237 4-mg tablets administered twice daily in the open-label phase (all subjects who completed the double-blind phase and entered the open-label phase transitioned to receive this treatment)
|
|---|---|---|---|---|
|
Infections and infestations
Corona virus infection
|
4.1%
11/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
7.5%
6/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
2.8%
7/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
4.0%
18/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
11/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
2.5%
2/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
2.0%
5/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
3.3%
15/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
|
Nervous system disorders
Headache
|
3.0%
8/266 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
6.2%
5/80 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
4.0%
10/252 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
2.0%
9/449 • 104 weeks (2 years)
AEs were ascertained at each study visit by asking the subject and study partner how the subject had been since the last visit. Additionally, AEs were also reported based on study safety assessments performed at each study visit.
|
Additional Information
Sotereos Gates, PhD
TauRx Therapeutics Management Ltd.
Phone: +44 (0) 7771 570707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place