Trial Outcomes & Findings for Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) (NCT NCT03444870)
NCT ID: NCT03444870
Last Updated: 2024-01-30
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
1053 participants
Primary outcome timeframe
Baseline, Week 116
Results posted on
2024-01-30
Participant Flow
Participants were enrolled in this study at 137 sites across 15 countries (Australia, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Lithuania, Peru, Russia, Taiwan, Spain, and the United States) during the global phase. Participants were enrolled at 21 sites in China during the China extension phase of the study. The open-label period in China was not started as the study was terminated early by the Sponsor.
A total of 985 participants with early (prodromal to mild) Alzheimer's Disease (AD) were randomized to either the gantenerumab (n=499) or placebo arm (n=486) to enter the double-blind treatment (DBT) period of the global phase. A total of 68 early (prodromal to mild) AD participants were randomized to the gantenerumab (n=35) or placebo arm (n=33) to enter the DBT period of the China extension phase.
Participant milestones
| Measure |
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, every four weeks (Q4W) up to Week 36 and then every two weeks (Q2W) up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
|
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection 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 injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
|
Global - OLE Period: Placebo (DBT) to Gantenerumab
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.
|
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
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 (DBT) Period
STARTED
|
486
|
499
|
33
|
35
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Intent-to-treat (ITT) Analysis Set
|
485
|
499
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Safety-evaluable (SE) Analysis Set
|
481
|
503
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
ITT Analysis Set (China)
|
0
|
0
|
33
|
35
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
SE Analysis Set (China)
|
0
|
0
|
33
|
35
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Safety Magnetic Resonance Imaging (MRI)-Evaluable (SEMRI) Analysis Set
|
476
|
497
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
COMPLETED
|
387
|
375
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
NOT COMPLETED
|
99
|
124
|
33
|
35
|
0
|
0
|
|
Open-Label Extension (OLE) Period
STARTED
|
0
|
0
|
0
|
0
|
10
|
19
|
|
Open-Label Extension (OLE) Period
SE Analysis Set
|
0
|
0
|
0
|
0
|
9
|
20
|
|
Open-Label Extension (OLE) Period
COMPLETED
|
0
|
0
|
0
|
0
|
7
|
17
|
|
Open-Label Extension (OLE) Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Global - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, every four weeks (Q4W) up to Week 36 and then every two weeks (Q2W) up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
China Extension - DBT Period: Placebo
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
|
China Extension - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection 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 injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
|
Global - OLE Period: Placebo (DBT) to Gantenerumab
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.
|
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
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 (DBT) Period
Study Terminated By Sponsor
|
0
|
0
|
30
|
35
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Reason not Specified
|
17
|
16
|
1
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Withdrawal by Subject
|
56
|
63
|
2
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Protocol Deviation
|
4
|
3
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Physician Decision
|
3
|
11
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Death
|
10
|
2
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Adverse Event
|
7
|
29
|
0
|
0
|
0
|
0
|
|
Double-Blind Treatment (DBT) Period
Randomized, but not Treated
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Extension (OLE) Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Open-Label Extension (OLE) Period
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Open-Label Extension (OLE) Period
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
Baseline characteristics by cohort
| Measure |
Global - DBT Period: Placebo
n=485 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=499 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
China Extension - DBT Period: Placebo
n=33 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
|
China Extension - DBT Period: Gantenerumab
n=35 Participants
Participants received gantenerumab, SC injection 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 injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
|
Total
n=1052 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 7.8 • n=485 Participants
|
71.1 years
STANDARD_DEVIATION 7.9 • n=499 Participants
|
65.9 years
STANDARD_DEVIATION 8.5 • n=33 Participants
|
68.5 years
STANDARD_DEVIATION 7.3 • n=35 Participants
|
71.4 years
STANDARD_DEVIATION 7.9 • n=1052 Participants
|
|
Sex: Female, Male
Female
|
255 Participants
n=485 Participants
|
290 Participants
n=499 Participants
|
16 Participants
n=33 Participants
|
18 Participants
n=35 Participants
|
579 Participants
n=1052 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=485 Participants
|
209 Participants
n=499 Participants
|
17 Participants
n=33 Participants
|
17 Participants
n=35 Participants
|
473 Participants
n=1052 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=485 Participants
|
52 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
110 Participants
n=1052 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
422 Participants
n=485 Participants
|
439 Participants
n=499 Participants
|
32 Participants
n=33 Participants
|
34 Participants
n=35 Participants
|
927 Participants
n=1052 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=485 Participants
|
8 Participants
n=499 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=35 Participants
|
15 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=485 Participants
|
18 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
36 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
Asian
|
53 Participants
n=485 Participants
|
52 Participants
n=499 Participants
|
33 Participants
n=33 Participants
|
35 Participants
n=35 Participants
|
173 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=485 Participants
|
0 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=485 Participants
|
1 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
7 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
White
|
398 Participants
n=485 Participants
|
414 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
812 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=485 Participants
|
0 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=1052 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=485 Participants
|
14 Participants
n=499 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=35 Participants
|
24 Participants
n=1052 Participants
|
|
China Extension: Clinical Dementia Rating-Sum of Boxes (CDR-SB)
|
—
|
—
|
3.29 score on a scale
STANDARD_DEVIATION 1.22 • n=33 Participants • ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
|
3.69 score on a scale
STANDARD_DEVIATION 1.50 • n=35 Participants • ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
|
3.49 score on a scale
STANDARD_DEVIATION 1.38 • n=68 Participants • ITT analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
|
|
DBT Period: CDR-SB
|
3.71 score on a scale
STANDARD_DEVIATION 1.67 • n=485 Participants • ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
|
3.71 score on a scale
STANDARD_DEVIATION 1.57 • n=499 Participants • ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
|
—
|
—
|
3.71 score on a scale
STANDARD_DEVIATION 1.62 • n=984 Participants • ITT analysis set included all participants randomized during the global phase, who received at least one dose of study drug.
|
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.
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 |
Global - DBT Period: Placebo
n=485 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=499 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
3.65 score on a scale
Standard Error 0.16
|
3.35 score on a scale
Standard Error 0.14
|
PRIMARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
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
Outcome data not reported
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 |
Global - DBT Period: Placebo
n=480 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=497 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
9.82 score on a scale
Standard Error 0.57
|
8.57 score on a scale
Standard Error 0.47
|
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 |
Global - DBT Period: Placebo
n=479 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=497 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
-12.32 score on a scale
Standard Error 0.68
|
-11.21 score on a scale
Standard Error 0.60
|
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 |
Global - DBT Period: Placebo
n=479 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=498 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Functional Activities Questionnaire (FAQ) Score
|
8.13 score on a scale
Standard Error 0.33
|
7.28 score on a scale
Standard Error 0.30
|
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.
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 |
Global - DBT Period: Placebo
n=485 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=499 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
-5.18 score on a scale
Standard Error 0.25
|
-4.86 score on a scale
Standard Error 0.23
|
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 |
Global - DBT Period: Placebo
n=481 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=498 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
8.42 score on a scale
Standard Error 0.52
|
7.44 score on a scale
Standard Error 0.43
|
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 |
Global - DBT Period: Placebo
n=481 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=499 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Change From Baseline to Week 116 in Verbal Fluency Task (VFT) Score
|
-3.46 score on a scale
Standard Error 0.31
|
-3.53 score on a scale
Standard Error 0.30
|
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 |
Global - DBT Period: Placebo
n=480 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=498 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
-6.47 score on a scale
Standard Error 0.64
|
-6.27 score on a scale
Standard Error 0.54
|
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 |
Global - DBT Period: Placebo
n=479 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=497 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
-10.80 score on a scale
Standard Error 0.56
|
-9.80 score on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)Population: SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set.
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Outcome measures
| Measure |
Global - DBT Period: Placebo
n=481 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=503 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With at Least One Adverse Event (AE)
|
423 Participants
|
454 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)Population: SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis 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 |
Global - DBT Period: Placebo
n=467 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=489 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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 Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation: Passive
|
13 Participants
|
17 Participants
|
|
DBT 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-Nonspecific
|
1 Participants
|
3 Participants
|
|
DBT 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
|
6 Participants
|
3 Participants
|
|
DBT 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 and Intent, But No Plan
|
2 Participants
|
0 Participants
|
|
DBT 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, Intent, and Plan
|
2 Participants
|
0 Participants
|
|
DBT 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
|
443 Participants
|
466 Participants
|
|
DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior: Interrupted Attempt
|
0 Participants
|
1 Participants
|
|
DBT 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
|
467 Participants
|
488 Participants
|
|
DBT 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
|
467 Participants
|
489 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)Population: SEMRI analysis set included all participants in the SE 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 |
Global - DBT Period: Placebo
n=476 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=497 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Magnetic Resonance Imaging (MRI) Finding
|
5 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)Population: SEMRI analysis set included all participants in the SE 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 |
Global - DBT Period: Placebo
n=476 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=497 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) MRI Finding
|
6 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)Population: SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis 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 |
Global - DBT Period: Placebo
n=481 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=503 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With Injection-Site Reactions
|
43 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 131 weeks)Population: SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, four participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set. Overall number analyzed is the number of participants with data available for analysis.
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 |
Global - DBT Period: Placebo
n=489 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
DBT Period: Number of Participants With Anti-Drug Antibodies (ADA) to Gantenerumab
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: Amyloid-PET modified ITT (mITT) analysis set included all participants in the ITT analysis set who participated in the Amyloid-PET substudy 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 |
Global - DBT Period: Placebo
n=41 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=49 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
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
|
9.06 score on a scale
Standard Error 3.046
|
-57.38 score on a scale
Standard Error 2.841
|
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 1 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. \[18F\] GTP1 was the tau PET radioligand. Tau load was measured using SUVR in 4 composite target ROIs: Temporal composite target region (left \& right)=anterior \& posterior superior temporal gyrus, posterior temporal lobe, fusiform gyrus, \& middle \& inferior temporal gyrus; Medial temporal composite region excluding hippocampus (left \& right): amygdala, parahippocampus \& anterior medial \& lateral temporal lobe; Frontal lobe (left \& right) \& Parietal lobe (left \& right). Inferior cerebellar grey matter=reference region for calculating SUVRs for all 4 regions. Tau-PET-mITT analysis set=all participants in ITT analysis set who participated in Tau PET sub-study \& who had at least one Tau PET scan with a 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 |
Global - DBT Period: Placebo
n=29 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=48 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
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
|
0.12 SUVR
Standard Error 0.018
|
0.13 SUVR
Standard Error 0.014
|
|
DBT Period: 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]
|
0.08 SUVR
Standard Error 0.014
|
0.09 SUVR
Standard Error 0.011
|
|
DBT Period: 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 0.012
|
0.08 SUVR
Standard Error 0.009
|
|
DBT Period: 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 0.020
|
0.09 SUVR
Standard Error 0.016
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF mITT 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 |
Global - DBT Period: Placebo
n=84 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=91 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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 - Total Tau (tTau)
|
3.2 percent change in tTau
Interval -1.74 to 8.37
|
-16.6 percent change in tTau
Interval -20.4 to -12.54
|
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 |
Global - DBT Period: Placebo
n=84 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=89 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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)
|
1.1 percent change in pTau-181
Interval -3.76 to 6.2
|
-25.2 percent change in pTau-181
Interval -28.65 to -21.49
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF mITT 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 |
Global - DBT Period: Placebo
n=85 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=93 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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 - Neurofilament Light Chain (NFL)
|
15.8 percent change in NFL
Interval 9.67 to 22.32
|
12.1 percent change in NFL
Interval 6.41 to 18.11
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: CSF mITT 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 |
Global - DBT Period: Placebo
n=84 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=93 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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
|
-0.6 percent change in neurogranin
Interval -5.93 to 5.05
|
-22.3 percent change in neurogranin
Interval -26.28 to -18.13
|
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
ADCS-ADL is a 23-item rater-administered, 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
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
MMSE is a rater-administered 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
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with 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
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 116Population: The study was terminated early by the sponsor before any participant had reached Week 116 visit in the China extension phase.
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
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)Population: SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. Total number of participants with at least one event (AEs) have been reported here.
Outcome measures
| Measure |
Global - DBT Period: Placebo
n=33 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=35 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
China - DBT Period: Number of Participants With at Least One AE
|
17 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)Population: SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug. 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 |
Global - DBT Period: Placebo
n=25 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=30 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Passive
|
1 Participants
|
1 Participants
|
|
China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: Active-Nonspecific (no method, intent, or plan)
|
0 Participants
|
1 Participants
|
|
China - 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
|
0 Participants
|
|
China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Ideation: No Event
|
23 Participants
|
28 Participants
|
|
China - DBT Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Behavior: No Event
|
25 Participants
|
30 Participants
|
|
China - 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
|
25 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)Population: SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
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 |
Global - DBT Period: Placebo
n=33 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=35 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
China - DBT Period: Number of Participants With at Least One ARIA-E MRI Finding
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)Population: SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
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 |
Global - DBT Period: Placebo
n=33 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=35 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
China - DBT Period: Number of Participants With at Least One ARIA-H MRI Finding
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 up to 14 weeks after the last dose of blinded study drug (up to 124 weeks)Population: SE analysis set (China) included all participants enrolled in China in the China extension phase who received at least one dose of study drug.
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 |
Global - DBT Period: Placebo
n=33 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=35 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
China - DBT Period: Number of Participants With Injection-Site Reactions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)Population: SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set, of which one participant entered OLE period.
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Outcome measures
| Measure |
Global - DBT Period: Placebo
n=9 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=20 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With at Least One AEs
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)Population: SE analysis set included all participants randomized during the global phase who received at least one dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety analysis set, of which one participant entered 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 |
Global - DBT Period: Placebo
n=6 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=19 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, 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 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 C-SSRS
Suicidal Ideation: No Event
|
6 Participants
|
18 Participants
|
|
OLE Period: Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS
Suicidal Behavior: No Event
|
6 Participants
|
19 Participants
|
|
OLE 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
|
6 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)Population: SEMRI analysis set included all participants in SE analysis set who had at least one post-baseline safety MRI scan. In DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in gantenerumab arm for SE analysis set, of which 1 participant entered OLE period.
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 |
Global - DBT Period: Placebo
n=9 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=20 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With at Least One ARIA-H MRI Finding
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From day of first dose in OLE period up to 14 weeks after the last OLE dose (up to 68 weeks)Population: SEMRI analysis set included all participants in SE analysis set who had at least one post-baseline safety MRI scan. In DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in gantenerumab arm for SE analysis set, of which 1 participant entered OLE period. Overall number analyzed is the number of participants with data available for analysis. Overall number analyzed is the number of participants with data available for analysis.
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 |
Global - DBT Period: Placebo
n=9 Participants
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=20 Participants
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
|---|---|---|
|
OLE Period: Number of Participants With at Least One ARIA-E MRI Finding
|
3 Participants
|
2 Participants
|
Adverse Events
Global - DBT Period: Placebo
Serious events: 95 serious events
Other events: 329 other events
Deaths: 11 deaths
Global - DBT Period: Gantenerumab
Serious events: 76 serious events
Other events: 366 other events
Deaths: 3 deaths
China Extension - DBT Period: Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
China Extension - DBT Period: Gantenerumab
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Global - OLE Period: Placebo (DBT) to Gantenerumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Global - DBT Period: Placebo
n=481 participants at risk
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=503 participants at risk
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
China Extension - DBT Period: Placebo
n=33 participants at risk
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
|
China Extension - DBT Period: Gantenerumab
n=35 participants at risk
Participants received gantenerumab, SC injection 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 injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
|
Global - OLE Period: Placebo (DBT) to Gantenerumab
n=9 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.
|
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
n=20 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.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Eye disorders
Glaucoma
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Femoral hernia strangulated
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
1.9%
9/481 • Number of events 9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.60%
3/503 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Medical device site abscess
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.0%
5/481 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Suspected COVID-19
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.2%
6/503 • Number of events 6 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.21%
1/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric leiomyoma
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gingival cancer
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.4%
7/503 • Number of events 8 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Clonic convulsion
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Subdural hygroma
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
VIth nerve paresis
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar artery dissection
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.99%
5/503 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Arterial occlusive disease
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Global - DBT Period: Placebo
n=481 participants at risk
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 114 weeks of the DBT period.
|
Global - DBT Period: Gantenerumab
n=503 participants at risk
Participants received gantenerumab, SC injection 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, and 510 mg, Q4W for 3 doses. Following this, from Week 36 onwards, participants received gantenerumab, SC injection at a dose of 510 mg, Q2W up to Week 114 of the DBT period.
|
China Extension - DBT Period: Placebo
n=33 participants at risk
Participants received gantenerumab matching placebo, SC injection, Q4W up to Week 36 and then Q2W up to approximately 110 weeks of the DBT period.
|
China Extension - DBT Period: Gantenerumab
n=35 participants at risk
Participants received gantenerumab, SC injection 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 injection at a dose of 510 mg, Q2W up to approximately 110 weeks of the DBT period.
|
Global - OLE Period: Placebo (DBT) to Gantenerumab
n=9 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.
|
Global - OLE Period: Gantenerumab (DBT) to Gantenerumab
n=20 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%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
26/481 • Number of events 29 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
6.6%
33/503 • Number of events 48 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
17/481 • Number of events 20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.2%
26/503 • Number of events 43 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
General disorders
Injection site reaction
|
8.9%
43/481 • Number of events 95 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
18.7%
94/503 • Number of events 392 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
2.5%
12/481 • Number of events 14 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.2%
6/503 • Number of events 6 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
General disorders
Vaccination site pain
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
COVID-19
|
7.3%
35/481 • Number of events 35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.2%
26/503 • Number of events 26 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
9.1%
3/33 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.4%
4/35 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Gingivitis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.0%
5/481 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
33/481 • Number of events 37 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
9.1%
46/503 • Number of events 60 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.62%
3/481 • Number of events 6 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.80%
4/503 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
1.2%
6/481 • Number of events 6 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.8%
9/503 • Number of events 10 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.8%
28/481 • Number of events 39 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
6.0%
30/503 • Number of events 37 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.7%
13/481 • Number of events 18 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
4.2%
21/503 • Number of events 23 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
8.7%
42/481 • Number of events 85 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.9%
60/503 • Number of events 99 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
12.9%
62/481 • Number of events 82 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.9%
60/503 • Number of events 94 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.7%
8/481 • Number of events 8 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.6%
8/503 • Number of events 8 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.80%
4/503 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.80%
4/503 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.60%
3/503 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.60%
3/503 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
29/481 • Number of events 36 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
7.4%
37/503 • Number of events 51 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
40/481 • Number of events 51 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.5%
43/503 • Number of events 49 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.62%
3/481 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.6%
13/503 • Number of events 15 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits
|
0.83%
4/481 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
6.6%
33/503 • Number of events 35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Amyloid related imaging abnormality-oedema/effusion
|
1.0%
5/481 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
20.3%
102/503 • Number of events 161 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.4%
4/35 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
33.3%
3/9 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.5%
41/481 • Number of events 49 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.9%
45/503 • Number of events 64 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.60%
3/503 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
1.2%
6/481 • Number of events 7 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
3.1%
15/481 • Number of events 18 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.0%
10/503 • Number of events 10 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
4.0%
19/481 • Number of events 21 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.8%
19/503 • Number of events 21 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
0.83%
4/481 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.99%
5/503 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
4.6%
22/481 • Number of events 22 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.6%
28/503 • Number of events 28 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
4.4%
21/481 • Number of events 23 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
25/503 • Number of events 26 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.83%
4/481 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.20%
1/503 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
11/481 • Number of events 13 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.8%
19/503 • Number of events 19 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
10.0%
2/20 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
7/481 • Number of events 7 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.99%
5/503 • Number of events 7 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.62%
3/481 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
7/481 • Number of events 8 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.6%
8/503 • Number of events 8 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.7%
13/481 • Number of events 13 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.4%
12/503 • Number of events 15 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
11.1%
1/9 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.3%
35/481 • Number of events 38 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.2%
41/503 • Number of events 54 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.5%
7/481 • Number of events 8 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.4%
12/503 • Number of events 13 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
22.2%
2/9 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/35 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.0%
1/20 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.42%
2/481 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.99%
5/503 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
9.1%
3/33 • Number of events 4 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.0%
5/481 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.60%
3/503 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
6.1%
2/33 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.9%
1/35 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
1.9%
9/481 • Number of events 10 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
2.6%
13/503 • Number of events 13 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 5 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.0%
1/33 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
19/481 • Number of events 23 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
3.8%
19/503 • Number of events 24 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
6.1%
2/33 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 6 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/481 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/503 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.21%
1/481 • Number of events 1 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.40%
2/503 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
8.6%
3/35 • Number of events 3 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
6/481 • Number of events 6 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
1.8%
9/503 • Number of events 9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/33 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
5.7%
2/35 • Number of events 2 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/9 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
0.00%
0/20 • Global: DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 131 weeks), OLE: Day 1 of OLE period up to 14 weeks post last OLE dose (up to 68 weeks); China DBT: Day 1 up to 14 weeks post last dose of blinded study drug (up to 124 weeks) All cause mortality: DBT: Day 1 up to the end of study (up to approximately 164 weeks); OLE period: From OLE Day 1 up to the end of the study (up to approximately 86 weeks)
SE analysis set=all participants randomized during global phase who received at least 1 dose of study drug. In the DBT period, 4 participants randomized to placebo arm received at least one dose of gantenerumab and were considered in the gantenerumab arm for safety evaluable set, of which 1 participant entered OLE period. SE analysis set (China)=all participants enrolled in China in China extension phase \& received at least 1 dose of study drug.
|
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