Trial Outcomes & Findings for Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) (NCT NCT03443973)
NCT ID: NCT03443973
Last Updated: 2024-01-17
Results Overview
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
975 participants
Primary outcome timeframe
Baseline, Week 116
Results posted on
2024-01-17
Participant Flow
Participants were enrolled in the study across 151 investigative sites in 18 countries from 22 August 2018 to 28 November 2022.
A total of 975 participants with early (prodromal to mild) Alzheimer's Disease (AD) were randomized to either the gantenerumab (n=498) or placebo arm (n=477) to enter the double-blind treatment (DBT) period.
Participant milestones
| Measure |
Placebo: DBT
Participants received, gantenerumab matching placebo, subcutaneous (SC) injections, every four weeks (Q4W) up to Week 36 and then every two weeks (Q2W) up to Week 114 of the DBT period.
|
Gantenerumab: DBT
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 milligrams (mg), Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
|
Gantenerumab (DBT) to Gantenerumab: OLE
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
|
|---|---|---|---|---|
|
Double-blind Treatment Period
STARTED
|
477
|
498
|
0
|
0
|
|
Double-blind Treatment Period
Safety-evaluable Set
|
474
|
501
|
0
|
0
|
|
Double-blind Treatment Period
COMPLETED
|
397
|
372
|
0
|
0
|
|
Double-blind Treatment Period
NOT COMPLETED
|
80
|
126
|
0
|
0
|
|
Open-label Extension Period
STARTED
|
0
|
0
|
13
|
14
|
|
Open-label Extension Period
COMPLETED
|
0
|
0
|
8
|
13
|
|
Open-label Extension Period
NOT COMPLETED
|
0
|
0
|
5
|
1
|
Reasons for withdrawal
| Measure |
Placebo: DBT
Participants received, gantenerumab matching placebo, subcutaneous (SC) injections, every four weeks (Q4W) up to Week 36 and then every two weeks (Q2W) up to Week 114 of the DBT period.
|
Gantenerumab: DBT
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 milligrams (mg), Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo (DBT) to Gantenerumab: Open-label Extension (OLE)
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
|
Gantenerumab (DBT) to Gantenerumab: OLE
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
|
|---|---|---|---|---|
|
Double-blind Treatment Period
Adverse Event
|
5
|
19
|
0
|
0
|
|
Double-blind Treatment Period
Death
|
5
|
7
|
0
|
0
|
|
Double-blind Treatment Period
Lack of Efficacy
|
1
|
1
|
0
|
0
|
|
Double-blind Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Double-blind Treatment Period
Reason Not Specified
|
9
|
11
|
0
|
0
|
|
Double-blind Treatment Period
Physician Decision
|
5
|
6
|
0
|
0
|
|
Double-blind Treatment Period
Protocol Deviation
|
1
|
2
|
0
|
0
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
54
|
79
|
0
|
0
|
|
Open-label Extension Period
Reason Not Specified
|
0
|
0
|
3
|
0
|
|
Open-label Extension Period
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
Baseline Characteristics
ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
Placebo: DBT
n=477 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
Gantenerumab: DBT
n=498 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Total
n=975 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 years
STANDARD_DEVIATION 7.4 • n=477 Participants
|
71.6 years
STANDARD_DEVIATION 7.8 • n=498 Participants
|
71.7 years
STANDARD_DEVIATION 7.6 • n=975 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=477 Participants
|
288 Participants
n=498 Participants
|
573 Participants
n=975 Participants
|
|
Sex: Female, Male
Male
|
192 Participants
n=477 Participants
|
210 Participants
n=498 Participants
|
402 Participants
n=975 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
119 Participants
n=477 Participants
|
112 Participants
n=498 Participants
|
231 Participants
n=975 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
358 Participants
n=477 Participants
|
386 Participants
n=498 Participants
|
744 Participants
n=975 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=477 Participants
|
0 Participants
n=498 Participants
|
0 Participants
n=975 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
13 Participants
n=477 Participants
|
13 Participants
n=498 Participants
|
26 Participants
n=975 Participants
|
|
Race (NIH/OMB)
Asian
|
75 Participants
n=477 Participants
|
56 Participants
n=498 Participants
|
131 Participants
n=975 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=477 Participants
|
0 Participants
n=498 Participants
|
0 Participants
n=975 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=477 Participants
|
5 Participants
n=498 Participants
|
9 Participants
n=975 Participants
|
|
Race (NIH/OMB)
White
|
385 Participants
n=477 Participants
|
424 Participants
n=498 Participants
|
809 Participants
n=975 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=477 Participants
|
0 Participants
n=498 Participants
|
0 Participants
n=975 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=477 Participants
|
0 Participants
n=498 Participants
|
0 Participants
n=975 Participants
|
|
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
|
3.52 score on a scale
STANDARD_DEVIATION 1.54 • n=477 Participants • ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
|
3.67 score on a scale
STANDARD_DEVIATION 1.61 • n=497 Participants • ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
|
3.60 score on a scale
STANDARD_DEVIATION 1.58 • n=974 Participants • ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
|
PRIMARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
CDR was derived through semi-structured interview with the participant and an appropriate informant, and it rated impairment across six domains: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care on a 5-point scale for which 0=no impairment, 0.5=questionable impairment, and 1, 2, and 3=mild, moderate, and severe impairment, respectively. The CDR-SB is based on summing each of the domain box scores with total score ranging from 0-18 with higher scores reflecting greater cognitive and functional impairment. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=497 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=477 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Global Outcome, as Measured by CDR-SB
|
2.82 score on a scale
Standard Error 0.14
|
3.01 score on a scale
Standard Error 0.15
|
PRIMARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)Population: OLE safety-evaluable set included all participants randomized during the global enrollment phase who received at least one dose of study drug and who entered the OLE period.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Outcome measures
| Measure |
Gantenerumab: DBT
n=14 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=13 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With Adverse Events (AEs)
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)Population: OLE safety-evaluable set included all participants randomized during the global enrollment phase who received at least one dose of study drug and who entered the OLE period. Overall number analyzed is the number of participants with data available for analysis.
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
Outcome measures
| Measure |
Gantenerumab: DBT
n=13 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=12 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Passive
|
0 Participants
|
1 Participants
|
|
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Active-Method, but no Intent or Plan
|
0 Participants
|
1 Participants
|
|
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: No Event
|
13 Participants
|
10 Participants
|
|
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: No event
|
13 Participants
|
12 Participants
|
|
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Self-injurious Behavior Without Suicidal Intent: No event
|
13 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)Population: MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan.
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
Outcome measures
| Measure |
Gantenerumab: DBT
n=14 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=13 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period : Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)Population: MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan.
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
Outcome measures
| Measure |
Gantenerumab: DBT
n=14 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=13 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks)Population: OLE safety-evaluable set included all participants randomized during the global enrollment phase who received at least one dose of study drug and who entered the OLE period.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
Outcome measures
| Measure |
Gantenerumab: DBT
n=14 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=13 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With Injection-Site Reactions
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 in addition to delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall \[DWR\] score is 0-10 and for Number Cancellation \[NC\] is 0-5, thus the score is ADAS-cog 11\[0-70\] plus the scores for DWR and NC). A higher score indicates worse performance. A negative change from baseline indicates improvement in cognitive function.
Outcome measures
| Measure |
Gantenerumab: DBT
n=491 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=475 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score
|
6.66 score on a scale
Standard Error 0.42
|
7.94 score on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
ADCS-ADL is a 23-item rater-administered, observer-reported outcome (ObsRO) that captures a participant's ability to perform basic activities of daily living (e.g., eating and toileting) and more complex ADL or instrumental activities of daily living (iADL, e.g., using the telephone, managing finances, preparing a meal). Total score ranges from 0-78, with higher scores reflecting better functioning. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=496 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=475 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study- Activities of Daily Living (ADCS-ADL) Total Score
|
-8.44 score on a scale
Standard Error 0.58
|
-9.26 score on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
FAQ is a rater-administered ObsRO (informant-based measure) that measures a participant's functional ability to perform complex higher-order activities. The observer provides performance ratings of the target person on ten complex higher-order activities. Total score that ranges from 0-30, with higher scores reflecting greater functional impairment. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=496 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=476 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
|
5.86 score on a scale
Standard Error 0.31
|
6.72 score on a scale
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
MMSE is a rater-administered performance-based outcome (PerfO) that includes a set of standardized questions used to evaluate possible cognitive impairment and help stage the severity level of this impairment. The questions target six areas: orientation, registration, attention, short-term recall, language, and constructional praxis/visuospatial abilities. Total score ranges from 0-30, with lower scores indicating greater impairment. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=497 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=477 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Mini-Mental State Examination (MMSE) Total Score
|
-4.00 score on a scale
Standard Error 0.20
|
-4.53 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=491 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=475 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Alzheimer Disease Assessment Scale-Cognition Subscale 11 (ADAS-Cog11) Score
|
5.77 score on a scale
Standard Error 0.38
|
6.97 score on a scale
Standard Error 0.46
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
VFT is a rater administered PerfO that measures speed and flexibility of verbal thought with a total score that ranges from 0-99 (lower scores indicating lower performance). A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=497 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=477 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score
|
-2.71 score on a scale
Standard Error 0.21
|
-2.68 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
Coding, also called DSST is a rater administered PerfO that measures speed of processing and associative memory with a total score that ranges from 0-135 (lower scores indicating lower performance). The DSST was adapted from the Wechsler Adult Intelligence Scale. The 120-second version of the test was used in this study. Positive change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=497 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=475 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in the Coding (Digit Symbol Substitution Test [DSST]) Subtest
|
-5.49 score on a scale
Standard Error 0.55
|
-6.90 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.
The ADCS-iADL measures activities such as using the telephone, shopping 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. Positive change from baseline indicates improvement.
Outcome measures
| Measure |
Gantenerumab: DBT
n=496 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=475 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Instrumental Score
|
-7.43 score on a scale
Standard Error 0.49
|
-8.22 score on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)Population: Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set.
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Outcome measures
| Measure |
Gantenerumab: DBT
n=501 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=474 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With AEs
|
451 Participants
|
409 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)Population: Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set. Overall number analyzed is the number of participants with data available for analysis.
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
Outcome measures
| Measure |
Gantenerumab: DBT
n=483 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=464 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Passive
|
12 Participants
|
20 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Active-Nonspecific
|
2 Participants
|
4 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Active-Method, But No Intent or Plan
|
2 Participants
|
2 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Active-Method and Intent, But No Plan
|
1 Participants
|
1 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Active-Method, Intent, and Plan
|
2 Participants
|
0 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: No Event
|
464 Participants
|
437 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Behavior: No Event
|
483 Participants
|
464 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Self-injurious Behavior, No Suicidal Intent
|
2 Participants
|
0 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Self-injurious Behavior Without Suicidal Intent: No Event
|
481 Participants
|
464 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)Population: MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan.
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces.
Outcome measures
| Measure |
Gantenerumab: DBT
n=496 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=470 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With ARIA-E Confirmed by MRI
|
128 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)Population: MRI Safety-evaluable analysis set included all participants in the Safety-evaluable analysis set who had at least one post-baseline safety MRI scan.
ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD.
Outcome measures
| Measure |
Gantenerumab: DBT
n=496 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=470 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With ARIA-H Confirmed by MRI
|
109 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)Population: Safety-evaluable set included all participants randomized during the global phase, who received at least one dose of study drug. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection.
Outcome measures
| Measure |
Gantenerumab: DBT
n=501 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=474 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With Injection-Site Reactions
|
75 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks)Population: ADA-evaluable analysis set included participants who received at least one dose of study drug and who provided at least one post-baseline ADA sample. In the DBT period, three participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm. As pre-specified in the protocol of study WN42171, ADA data for studies WN29922 and WN39658 from the OLE period will be reported in the results of study WN42171 (NCT04374253).
The number of participants with positive results for ADA against gantenerumab at any of the post-baseline assessment time-points were reported. Participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA = A participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result.
Outcome measures
| Measure |
Gantenerumab: DBT
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=501 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab
|
—
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: Amyloid-PET-modified-ITT (mITT) included all participants in the ITT analysis set who participated in the Amyloid PET sub-study and who had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol and who did not withdraw from the Amyloid PET substudy before randomization. Overall number analyzed is the number of participants with data available for analysis.
Brain amyloid load over time was assessed using \[18F\] florbetaben or \[18F\] flutemetamol tracers. These are PET radioligand selective to amyloid. Amyloid PET burden was measured in a composite region of interest (ROI) by using standardized uptake value ratio (SUVR) mapped to the centiloid scale. The weighted composite target region are composed of (both left and right side): frontal lobe, parietal lobe, temporal lobe lateral, cingulum posterior and anterior cingulate gyrus. The reference region used to normalize the composite region was the whole cerebellum. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan.
Outcome measures
| Measure |
Gantenerumab: DBT
n=40 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=44 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
Change From Baseline to Week 116 in Brain Amyloid Load as Measured by Amyloid Positron Emission Tomography (PET) Scan in a Subset of Participants
|
-48.00 score on a scale
Standard Error 2.845
|
8.46 score on a scale
Standard Error 2.768
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: As pre-specified in protocol/SAP single tau PET substudy analyzed participants from 2 studies i.e. WN29922 (NCT03444870) \& WN39658 (NCT03443973), hence data for Tau PET was analyzed at pooled level of WN29922 \&WN39658. These studies had identical study design \&enrolled an Early AD population. Tau PET analysis was planned in a subset of participants, to get an optimum sample size for analysis, it was pre-planned to conduct one tau PET substudy for participants willing to consent to the procedure.
Change in tau load= how much neurofibrillary tau pathology is present in brain assessed by PET Scan. Tau PET radioligand used was \[18F\] GTP1. Tau load was measured using SUVR in 4 composite target ROIs: Temporal target region included (both left \& right)=anterior \&posterior superior temporal gyrus, posterior temporal lobe, fusiform gyrus, \&middle \&inferior temporal gyrus; Medial temporal region excluding hippocampus included (both left \& right): amygdala, parahippocampus \& anterior medial \& lateral temporal lobe; Frontal lobe (both left \& right) \& Parietal lobe (both left \& right). Inferior cerebellar grey matter=reference region for calculating SUVRs for 4 target regions. Tau-PET-mITT analysis set=all participants in ITT analysis set who participated in Tau PET sub-study \& had at least one Tau PET scan with valid quantitative measurement \& who did not withdraw from Tau PET substudy before randomization. Overall number analyzed=number of participants with data available for analysis.
Outcome measures
| Measure |
Gantenerumab: DBT
n=48 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=29 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
ROI: Temporal Composite Region
|
0.13 SUVR
Standard Error 0.014
|
0.12 SUVR
Standard Error 0.018
|
|
Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
ROI: Medial Temporal Composite Region [not including the Hippocampus]
|
0.09 SUVR
Standard Error 0.011
|
0.08 SUVR
Standard Error 0.014
|
|
Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
ROI: Frontal Lobe
|
0.08 SUVR
Standard Error 0.009
|
0.08 SUVR
Standard Error 0.012
|
|
Change From Baseline to Week 116 in Brain Tau Load, as Measured by Tau PET Scan in a Subset of Participants
ROI: Parietal Lobe
|
0.09 SUVR
Standard Error 0.016
|
0.09 SUVR
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF modified ITT analysis set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
NFL is a neuronal cytoplasmic protein highly expressed in large, myelinated axons. Its levels increase in CSF and blood proportionally to the degree of axonal damage in a variety of neurological disorders, including AD.
Outcome measures
| Measure |
Gantenerumab: DBT
n=74 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=72 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Percent Change From Baseline to Week 116 in Cerebrospinal Fluid (CSF) Marker of Disease in a Subset of Participants - Neurofilament Light Chain (NFL)
|
8.9 percent change in NFL
Interval 0.6 to 17.83
|
25.5 percent change in NFL
Interval 15.83 to 35.97
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF modified ITT analysis set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Gantenerumab: DBT
n=72 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=72 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Neurogranin
|
-19.6 percent change in neurogranin
Interval -24.66 to -14.3
|
-6.1 percent change in neurogranin
Interval -11.99 to 0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF modified ITT analysis set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of tau, as well as specific pTau species, is thought to be a marker for progressive cellular degeneration in AD.
Outcome measures
| Measure |
Gantenerumab: DBT
n=71 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=72 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Total Tau (tTau)
|
-16.4 percent change in tTau
Interval -21.55 to -10.87
|
1.8 percent change in tTau
Interval -4.46 to 8.45
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF modified ITT analysis set included all participants in the ITT analysis set who had at least one valid quantitative CSF measurement. Overall number analyzed is the number of participants with data available for analysis.
CSF phospho-tau is an indicator of neuronal injury and neurodegeneration. CSF biomarker tTau has been considered as a general marker of neurodegeneration. An elevation in levels of pTau species, is thought to be a marker for progressive cellular degeneration in AD.
Outcome measures
| Measure |
Gantenerumab: DBT
n=70 Participants
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo: DBT
n=71 Participants
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Percent Change From Baseline to Week 116 in CSF Marker of Disease in a Subset of Participants - Phosphorylated Tau (pTau-181)
|
-20.9 percent change in pTau-181
Interval -26.17 to -15.31
|
0.1 percent change in pTau-181
Interval -6.5 to 7.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on Days 1, Weeks 24, 52 and 76; Post-dose on Day 4, Weeks 41, 103, and 115Population: Pharmacokinetic(PK)-evaluable analysis set included participants who received at least one dose of study drug and who provided at least one valid post-baseline PK sample.
Outcome measures
Outcome data not reported
Adverse Events
Placebo: DBT
Serious events: 63 serious events
Other events: 296 other events
Deaths: 5 deaths
Gantenerumab: DBT
Serious events: 61 serious events
Other events: 358 other events
Deaths: 7 deaths
Placebo (DBT) to Gantenerumab: OLE
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Gantenerumab (DBT) to Gantenerumab: OLE
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo: DBT
n=474 participants at risk
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
Gantenerumab: DBT
n=501 participants at risk
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo (DBT) to Gantenerumab: OLE
n=13 participants at risk
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
|
Gantenerumab (DBT) to Gantenerumab: OLE
n=14 participants at risk
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
|
|---|---|---|---|---|
|
Infections and infestations
Labyrinthitis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Periodontitis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Pneumonia
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.80%
4/501 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Postoperative wound infection
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Pyelonephritis
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Sepsis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Urinary tract infection
|
0.63%
3/474 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.80%
4/501 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Urosepsis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
5/474 • Number of events 5 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.60%
3/501 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Investigations
SARS-CoV-2 test positive
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Lacunar infarction
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Peripheral paralysis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Seizure
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Speech disorder
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Syncope
|
0.63%
3/474 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Alcoholism
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Delusion
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Renal and urinary disorders
Haematuria
|
0.21%
1/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Bundle branch block left
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Constipation
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.21%
1/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
General disorders
Pyrexia
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
General disorders
Sudden cardiac death
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
COVID-19
|
0.63%
3/474 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.60%
3/501 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Chronic sinusitis
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Endocarditis bacterial
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
Other adverse events
| Measure |
Placebo: DBT
n=474 participants at risk
Participants received, gantenerumab matching placebo, SC injections, Q4W up to Week 36 and then Q2W up to Week 114 of the DBT period.
|
Gantenerumab: DBT
n=501 participants at risk
Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injections, at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
Placebo (DBT) to Gantenerumab: OLE
n=13 participants at risk
Participants who received gantenerumab matching placebo in the DBT period received gantenerumab SC injections with gradual up titration starting at a dose of 120 mg, Q4W for 3 doses, followed by 255 mg, Q4W for 3 doses, and then at a dose of 510 mg, Q4W up to Week 34 of the OLE period. To maintain the blind to previous treatment assignment, participants received Q2W, SC injections, with alternate doses containing gantenerumab matching placebo.
|
Gantenerumab (DBT) to Gantenerumab: OLE
n=14 participants at risk
Participants who received gantenerumab in the DBT period continued receiving gantenerumab, SC injections, 510 mg, Q2W up to Week 34 of the OLE period.
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
15/474 • Number of events 16 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
2.2%
11/501 • Number of events 12 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
25/474 • Number of events 33 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.8%
39/501 • Number of events 44 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
13/474 • Number of events 20 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
4.4%
22/501 • Number of events 38 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
General disorders
Fatigue
|
2.5%
12/474 • Number of events 15 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
3.0%
15/501 • Number of events 17 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
General disorders
Injection site reaction
|
6.5%
31/474 • Number of events 58 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
15.0%
75/501 • Number of events 319 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 5 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
COVID-19
|
6.3%
30/474 • Number of events 31 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.2%
36/501 • Number of events 36 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Groin infection
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
49/474 • Number of events 62 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
9.0%
45/501 • Number of events 53 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Oral candidiasis
|
0.42%
2/474 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Pharyngitis
|
1.1%
5/474 • Number of events 7 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.80%
4/501 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Suspected COVID-19
|
1.1%
5/474 • Number of events 5 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
1.6%
8/501 • Number of events 8 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
24/474 • Number of events 26 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
5.8%
29/501 • Number of events 38 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Infections and infestations
Urinary tract infection
|
5.5%
26/474 • Number of events 38 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
6.4%
32/501 • Number of events 34 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Fall
|
9.9%
47/474 • Number of events 58 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
9.4%
47/501 • Number of events 74 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
15.4%
2/13 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Head injury
|
1.5%
7/474 • Number of events 7 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
1.2%
6/501 • Number of events 6 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.9%
9/474 • Number of events 12 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
1.00%
5/501 • Number of events 8 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.9%
9/474 • Number of events 10 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
2.0%
10/501 • Number of events 15 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.84%
4/474 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.40%
2/501 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
42/474 • Number of events 49 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.8%
39/501 • Number of events 47 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.63%
3/474 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.60%
3/501 • Number of events 3 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
32/474 • Number of events 39 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
5.8%
29/501 • Number of events 33 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.84%
4/474 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
1.2%
6/501 • Number of events 6 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
25/474 • Number of events 27 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
3.0%
15/501 • Number of events 18 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
0.42%
2/474 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
6.6%
33/501 • Number of events 35 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
2.5%
12/474 • Number of events 15 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
22.8%
114/501 • Number of events 162 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.80%
4/501 • Number of events 5 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Dizziness
|
6.1%
29/474 • Number of events 36 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.8%
39/501 • Number of events 54 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Headache
|
10.5%
50/474 • Number of events 64 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
12.8%
64/501 • Number of events 118 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Nervous system disorders
Syncope
|
1.9%
9/474 • Number of events 9 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
2.8%
14/501 • Number of events 17 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Aggression
|
0.42%
2/474 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Anxiety
|
4.6%
22/474 • Number of events 23 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
5.2%
26/501 • Number of events 31 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Psychiatric disorders
Confusional state
|
1.1%
5/474 • Number of events 6 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
2.6%
13/501 • Number of events 14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/501 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.84%
4/474 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
1.00%
5/501 • Number of events 6 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Hypertension
|
7.4%
35/474 • Number of events 40 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
6.8%
34/501 • Number of events 38 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
15.4%
2/13 • Number of events 2 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
1/474 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.80%
4/501 • Number of events 4 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/13 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.1%
1/14 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/474 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.20%
1/501 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
7.7%
1/13 • Number of events 1 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
0.00%
0/14 • DBT Period: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 128 weeks); OLE Period: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 48 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approx. 86 weeks)
All-cause mortality was reported based on ITT analysis set=all randomized participants. SAEs \& other AEs reported based on safety-evaluable set=all participants randomized during global phase \& received at least one dose of study drug. 3 participants randomized to placebo received at least one dose of gantenerumab and were represented in gantenerumab arm; OLE safety set=all participants randomized during global enrollment phase who received at least one dose of study drug \& entered OLE period.
|
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