Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD). (NCT NCT02670083)
NCT ID: NCT02670083
Last Updated: 2020-07-16
Results Overview
The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy.
TERMINATED
PHASE3
813 participants
Baseline, Week 105
2020-07-16
Participant Flow
The study was conducted at 249 centers in 30 countries.
A total of 813 participants were enrolled at 249 centers. 4 participants did not receive any study treatment meaning that the modified intent-to-treat and safety populations both consisted of 809 participants.
Participant milestones
| Measure |
Placebo
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
409
|
404
|
|
Overall Study
COMPLETED
|
88
|
85
|
|
Overall Study
NOT COMPLETED
|
321
|
319
|
Reasons for withdrawal
| Measure |
Placebo
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
13
|
|
Overall Study
Death
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Multiple Reasons
|
9
|
9
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Study Terminated By Sponsor
|
257
|
254
|
|
Overall Study
Symptomatic Deterioration
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
32
|
31
|
|
Overall Study
Non-Compliance With Study Drug
|
1
|
0
|
Baseline Characteristics
A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).
Baseline characteristics by cohort
| Measure |
Placebo
n=409 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=404 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
Total
n=813 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.3 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
71.0 Years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
70.7 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
483 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
361 Participants
n=5 Participants
|
369 Participants
n=7 Participants
|
730 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Stated
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
360 Participants
n=5 Participants
|
352 Participants
n=7 Participants
|
712 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The CDR-SB rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline for this primary endpoint. Data after 29 January 2019 are censored for the primary and secondary efficacy analyses to avoid potential biases due to investigators, participants, raters, etc. being potentially influenced by early closure of the study due to lack of efficacy.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=86 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score
|
3.42 Units on a Scale
Standard Error 0.263
|
3.59 Units on a Scale
Standard Error 0.264
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=80 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 13 (ADAS-Cog-13)
|
9.55 Units on a Scale
Standard Error 0.824
|
9.82 Units on a Scale
Standard Error 0.841
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The ADAS-Cog-11 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The score range for ADAS-Cog-11 is from 0 to 70 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=80 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 on Cognition, as Assessed by Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) (Subscale) 11 (ADAS-Cog-11)
|
8.43 Units on a Scale
Standard Error 0.758
|
8.53 Units on a Scale
Standard Error 0.773
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The CDR-GS represents a semi-structured interview which rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) on a 5-point scale in which CDR 0 = no dementia and CDR 0.5, 1, 2 or 3 = questionable, mild, moderate or severe dementia respectively. The range in scores for the CDR-GS is from 0 to 3 and a high score on the CDR-GS would indicate a high disease severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=88 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=86 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the CDR-Global Score (CDR-GS)
|
0.55 Units on a Scale
Standard Error 0.056
|
0.50 Units on a Scale
Standard Error 0.056
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The MMSE is a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target 6 areas: orientation, registration, attention, short-term recall, language and constructional praxis/visuospatial abilities. The scores on the MMSE range from 0 to 30, with higher scores indicating better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=90 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=87 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 on Severity of Dementia, Assessed Using the Mini Mental State Evaluation (MMSE)
|
-4.63 Units on a Scale
Standard Error 0.377
|
-4.96 Units on a Scale
Standard Error 0.383
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=90 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=88 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 on Function as Assessed by the ADCS-ADL Total Score
|
-11.51 Units on a Scale
Standard Error 1.226
|
-13.39 Units on a Scale
Standard Error 1.242
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The ADCS-iADL (Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living) measures activities such as using the telephone, managing finances and preparing a meal. The ADCS-iADL consists of 16 questions with a score range of 0 to 56 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=90 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=88 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 on Function as Assessed by the ADCS-instrumental (ADCS-iADL) Subscore
|
-9.22 Units on a Scale
Standard Error 0.967
|
-10.44 Units on a Scale
Standard Error 0.979
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: Please note that for this Outcome Measure, no participants were evaluated at all as the derivation of this endpoint was not pre-specified before the Sponsor terminated the study and therefore it was not reported.
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The NPI-Q is an informant-based instrument that evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavioral disturbances and appetite and eating abnormalities. The severity of each neuropsychiatric symptom is rated on a 3-point scale (mild, moderate and marked). The total severity score range is from 0 to 36 with higher scores representing higher severity. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=87 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Change From Baseline to Week 105 Assessed Using the Neuropsychiatric Inventory Questionnaire (NPI-Q)
|
1.02 Units on a Scale
Standard Error 0.562
|
1.55 Units on a Scale
Standard Error 0.556
|
SECONDARY outcome
Timeframe: Baseline up to Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The QoL-AD (Quality of Life - Alzheimer's Disease) scale assesses QoL in participants who have dementia. The QoL-AD consists of 13 items covering aspects of participants' relationships with friends and family, physical condition, mood, concerns about finances and overall assessment of QoL. Items are rated on 4-point Likert-type scales ranging from 1 \[poor\] to 4 \[excellent\]. The score range is from 13 to 52, with higher scores indicating a better QoL. The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=90 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=86 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
|
-1.69 Units on a Scale
Standard Error 0.501
|
-2.08 Units on a Scale
Standard Error 0.513
|
SECONDARY outcome
Timeframe: Baseline up to Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The ZCI-AD is a modified version of the Zarit Burden Interview, which was originally designed to reflect the stresses experienced by caregivers of people with dementia. This modified version includes slight modifications in item and title wording (e.g., removal of "your relative" to refer directly to the patient, removal of "burden" from title) and the use of 11-point numerical rating scales. The ZCI-AD scale consists of a total of 30 items. Total scores will be calculated with a total score range from 0 to 300 (higher scores indicate a higher burden on the caregiver). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=87 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Zarit Caregiver Interview for Alzheimer's Disease (ZCI-AD) Scale Score
|
22.72 Units on a Scale
Standard Error 5.135
|
24.11 Units on a Scale
Standard Error 5.106
|
SECONDARY outcome
Timeframe: Baseline up to Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=87 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
EQ-5D Questionnaire Domain Score for Participants
|
-4.54 Units on a Scale
Standard Error 1.732
|
-6.35 Units on a Scale
Standard Error 1.761
|
SECONDARY outcome
Timeframe: Baseline up to Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
The EQ-5D is a standardized measure of health status designed to provide a simple generic measure of health for clinical and economic appraisal. It is broadly applicable across a wide range of health conditions and treatment. The EQ-5D assesses five domains to provide a health state index. These are anxiety/depression, pain/discomfort, usual activities, mobility, and self-care. The scores on the EQ-5D ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). The difference in mean change from Baseline to Week 105 between Crenezumab and Placebo treated participants was estimated. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=88 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
EQ-5D Questionnaire Domain Score for Caregivers
|
-3.16 Units on a Scale
Standard Error 1.713
|
-4.09 Units on a Scale
Standard Error 1.721
|
SECONDARY outcome
Timeframe: Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).Population: The Safety analysis population included all randomized participants who received at least 1 dose of study drug with participants grouped according to actual treatment received. If a participant received at least 2 vials of crenezumab, then they were placed in the crenezumab arm.
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Placebo
n=405 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=404 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)
AEs
|
83.2 Percentage
|
85.9 Percentage
|
|
Percentage of Participants With Adverse Event (AEs) and Serious Adverse Event (SAEs)
SAEs
|
15.6 Percentage
|
16.6 Percentage
|
SECONDARY outcome
Timeframe: Baseline up to Week 105Population: The Safety analysis population included all randomized participants who received at least 1 dose of study drug with participants grouped according to actual treatment received. If a participant received at least 2 vials of crenezumab, then they were placed in the crenezumab arm. Data below is only for participants included in the actual analysis.
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Outcome measures
| Measure |
Placebo
n=385 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=404 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Percentage of Participants With Anti-Crenezumab Antibodies
Baseline ADAs
|
0.3 Percentage
|
0.2 Percentage
|
|
Percentage of Participants With Anti-Crenezumab Antibodies
Treatment Emergent ADAs
|
0.5 Percentage
|
0.5 Percentage
|
SECONDARY outcome
Timeframe: Pre-infusion (0 hour), 60-90 minutes post-infusion on Day 1 Week 1 and on Week 25; Weeks 13, 37 (Pre-dose), 53, 77 and 105 (infusion length = as per the Pharmacy Manual)Population: The PK Analysis population was defined as all participants who have received at least one dose of crenezumab and with at least one evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis.
Serum concentration data for Crenezumab will be tabulated and summarized. Descriptive summary statistics will include the arithmetic mean and SD. Since a sparse PK sampling design is being used, population (non-linear mixed-effects) modeling will be used to analyze the dose concentration-time data of crenezumab. Information from other clinical studies may be incorporated to establish the PK model. Please note that Post-dose samples were not collected at Weeks 37 and 105.
Outcome measures
| Measure |
Placebo
n=392 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Serum Concentration of Crenezumab
Week 1 Day 1 Predose
|
NA ug/mL
Standard Deviation NA
No Drug was administered at this point so no concentrations detected.
|
—
|
|
Serum Concentration of Crenezumab
Week 1 Day 1 Postdose
|
1350 ug/mL
Standard Deviation 319
|
—
|
|
Serum Concentration of Crenezumab
Week 13 Predose
|
345 ug/mL
Standard Deviation 146
|
—
|
|
Serum Concentration of Crenezumab
Week 13 Postdose
|
1580 ug/mL
Standard Deviation 487
|
—
|
|
Serum Concentration of Crenezumab
Week 25 Predose
|
369 ug/mL
Standard Deviation 130
|
—
|
|
Serum Concentration of Crenezumab
Week 25 Postdose
|
1700 ug/mL
Standard Deviation 443
|
—
|
|
Serum Concentration of Crenezumab
Week 37 Predose
|
368 ug/mL
Standard Deviation 152
|
—
|
|
Serum Concentration of Crenezumab
Week 53 Predose
|
393 ug/mL
Standard Deviation 164
|
—
|
|
Serum Concentration of Crenezumab
Week 53 Postdose
|
1800 ug/mL
Standard Deviation 420
|
—
|
|
Serum Concentration of Crenezumab
Week 77 Predose
|
410 ug/mL
Standard Deviation 261
|
—
|
|
Serum Concentration of Crenezumab
Week 77 Postdose
|
1790 ug/mL
Standard Deviation 496
|
—
|
|
Serum Concentration of Crenezumab
Week 105
|
408 ug/mL
Standard Deviation 186
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1; Weeks 13, 25, 53, 77 and 105Population: The PD Analysis population was defined as all participants who have received at least one dose of crenezumab and with at least one evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis.
Plasma Abeta 40 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that a Post-dose sample was only collected at Week 13.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 105 Predose
|
48.6 ng/mL
Standard Deviation 14.0
|
—
|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 1 Day 1 Predose
|
0.377 ng/mL
Standard Deviation 0.136
|
—
|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 13 Predose
|
44.6 ng/mL
Standard Deviation 10.0
|
—
|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 13 Postdose
|
44.3 ng/mL
Standard Deviation 9.5
|
—
|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 25 Predose
|
46.4 ng/mL
Standard Deviation 10.1
|
—
|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 53 Predose
|
48.8 ng/mL
Standard Deviation 10.7
|
—
|
|
Plasma Amyloid Beta (Abeta) 40 Concentrations
Week 77 Predose
|
47.5 ng/mL
Standard Deviation 12.2
|
—
|
SECONDARY outcome
Timeframe: Week 1 Day 1; Weeks 13, 25, 53, 77 and 105Population: The PD Analysis population was defined as all participants who have received at least one dose of crenezumab and with at least one evaluable post-dose PK sample. Data presented below is only for participants that were included in the actual analysis.
Plasma Abeta 42 concentrations will be measured over time and descriptive summary statistics will include the arithmetic mean and SD. Please note that a Post-dose sample was only collected at Week 13.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 1 Day 1 Predose
|
0.0335 ng/mL
Standard Deviation 0.00812
|
—
|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 13 Predose
|
2.72 ng/mL
Standard Deviation 0.553
|
—
|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 13 Postdose
|
2.71 ng/mL
Standard Deviation 0.602
|
—
|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 25 Predose
|
2.73 ng/mL
Standard Deviation 0.55
|
—
|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 53 Predose
|
2.87 ng/mL
Standard Deviation 0.589
|
—
|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 77 Predose
|
2.79 ng/mL
Standard Deviation 0.68
|
—
|
|
Plasma Amyloid Beta (Abeta) 42 Concentrations
Week 105 Predose
|
2.87 ng/mL
Standard Deviation 0.818
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
Percentage Change in Whole Brain Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=180 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=172 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Percentage Change From Baseline to Week 105 in Whole Brain Volume as Determined by Magnetic Resonance Imaging (MRI)
|
-2.66 Percentage
Standard Error 0.091
|
-2.65 Percentage
Standard Error 0.092
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
Percentage Change in Ventricle Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=189 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=181 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Percentage Change From Baseline to Week 105 in Ventricle Volume as Determined by Magnetic Resonance Imaging (MRI)
|
22.29 Percentage
Standard Error 0.907
|
23.57 Percentage
Standard Error 0.912
|
SECONDARY outcome
Timeframe: Baseline, Week 105Population: The Modified Intent-To-Treat population (Placebo (n = 407); Cren (n = 402)) was defined as all randomized participants who received at least 1 dose of study drug, with participants grouped according to the treatment assigned at randomization. Data presented below is only for participants that were included in the actual analysis.
Percentage Change in Hippocampal Volume will be measured over time and descriptive summary statistics will include the arithmetic mean, median, range, SD, and coefficient of variation, as appropriate. Mixed model repeated measures (MMRMs) adjusting for disease severity, APOEe4 status, geographic region, and the use or non-use of anti-dementia medications at baseline were used to estimate the mean change from baseline.
Outcome measures
| Measure |
Placebo
n=169 Participants
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=160 Participants
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Percentage Change From Baseline to Week 105 in Hippocampal Volume as Determined by Magnetic Resonance Imaging (MRI)
|
-6.57 Percentage
Standard Error 0.200
|
-6.97 Percentage
Standard Error 0.203
|
Adverse Events
Placebo
Crenezumab
Serious adverse events
| Measure |
Placebo
n=405 participants at risk
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=404 participants at risk
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE INTERSTITIAL PNEUMONITIS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Surgical and medical procedures
CORONARY ARTERY BYPASS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Surgical and medical procedures
SKIN NEOPLASM EXCISION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Surgical and medical procedures
URETHRAL STENT INSERTION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
BRADYCARDIA
|
0.49%
2/405 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
CARDIAC ARREST
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.49%
2/405 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Ear and labyrinth disorders
VERTIGO
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Endocrine disorders
HYPERPARATHYROIDISM PRIMARY
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
COLITIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER HAEMORRHAGE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
GASTROINTESTINAL VASCULAR MALFORMATION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
General disorders
CHEST PAIN
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
General disorders
DEATH
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.49%
2/405 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
CELLULITIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
DIVERTICULITIS
|
0.74%
3/405 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
PNEUMONIA
|
0.74%
3/405 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
1.2%
5/404 • Number of events 5 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
TUBERCULOSIS OF CENTRAL NERVOUS SYSTEM
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
UROSEPSIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
VIRAL INFECTION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
FALL
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.99%
4/404 • Number of events 4 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.74%
3/405 • Number of events 4 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.99%
4/404 • Number of events 5 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.25%
1/405 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
TRAUMATIC INTRACRANIAL HAEMORRHAGE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.49%
2/405 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.74%
3/404 • Number of events 5 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.49%
2/405 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.49%
2/405 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC SCLERODERMA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOPROLIFERATIVE DISORDER
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
CEREBROVASCULAR DISORDER
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
DEMENTIA ALZHEIMER'S TYPE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.49%
2/405 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
PARAESTHESIA
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
SYNCOPE
|
0.99%
4/405 • Number of events 4 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.74%
3/404 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Product Issues
DEVICE FAILURE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
AGITATION
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.50%
2/404 • Number of events 2 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
DELIRIUM
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
DELUSION
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
PERSONALITY CHANGE
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
SCHIZOPHRENIA
|
0.25%
1/405 • Number of events 1 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.00%
0/404 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/405 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
0.25%
1/404 • Number of events 3 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
Other adverse events
| Measure |
Placebo
n=405 participants at risk
Participants received intravenous (IV) infusion of Placebo every 4 weeks (Q4W) for 100 weeks.
|
Crenezumab
n=404 participants at risk
Participants received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W) for 100 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
6.4%
26/405 • Number of events 42 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
6.2%
25/404 • Number of events 27 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
BRONCHITIS
|
3.2%
13/405 • Number of events 13 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
5.2%
21/404 • Number of events 21 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.1%
33/405 • Number of events 41 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
9.9%
40/404 • Number of events 50 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.2%
29/405 • Number of events 38 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
8.2%
33/404 • Number of events 36 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.4%
22/405 • Number of events 29 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
5.0%
20/404 • Number of events 22 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Injury, poisoning and procedural complications
FALL
|
8.1%
33/405 • Number of events 42 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
10.4%
42/404 • Number of events 60 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Investigations
WEIGHT DECREASED
|
2.7%
11/405 • Number of events 11 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
5.4%
22/404 • Number of events 22 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.7%
31/405 • Number of events 36 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
6.4%
26/404 • Number of events 38 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
DIZZINESS
|
6.7%
27/405 • Number of events 34 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
5.7%
23/404 • Number of events 28 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Nervous system disorders
HEADACHE
|
11.1%
45/405 • Number of events 60 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
9.7%
39/404 • Number of events 48 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
ANXIETY
|
5.2%
21/405 • Number of events 24 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
6.9%
28/404 • Number of events 31 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Psychiatric disorders
DEPRESSION
|
6.7%
27/405 • Number of events 27 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
6.9%
28/404 • Number of events 28 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.4%
22/405 • Number of events 26 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
1.7%
7/404 • Number of events 8 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
|
Vascular disorders
HYPERTENSION
|
5.4%
22/405 • Number of events 22 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
6.7%
27/404 • Number of events 29 • Baseline up until 16 weeks after the last dose of study drug (up to 117 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER