Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease (NCT NCT03761849)

NCT ID: NCT03761849

Last Updated: 2024-03-01

Results Overview

cUHDRS includes the Total Functional Capacity (range, 0-13; higher score means better functioning), Total Motor Score (range, 0-124; higher score means worse motor severity), Symbol Digit Modality Test (range, 0-110, correctly paired numbers-symbols in 90 seconds; higher score means better cognitive performance), and Stroop Word Reading (range, 0-no max value, correctly read colour words in 45 seconds; higher score means better cognitive performance) scores. A z-score for each test is calculated, which alone can be used to describe relationship between an individual's test score and the mean score of a target population. A z-score of 0 is the mean, and ±1 is 1 standard deviation from the mean. For cUHDRS, z-scores of each test are summed, whereby a higher cUHDRS score is better (score of -3.06-no max value) and a change of ≥1.2 is a meaningful worsening, shown to track functional decline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 899 participants
• Primary outcome timeframe: Weeks 21 for ODC and 69 for NDC
• Results posted on: 2024-03-01

Participant Flow

Study BN40423 was originally designed (under Protocol v1-3) to include three dosing regimens under a double-blinded monthly dosing paradigm: tominersen Q4W, tominersen every 8 weeks (Q8W) with alternating placebo, and placebo Q4W. The Sponsor decided to stop enrollment into the ODC and NDC started with new participants with 120mg tominersen Q8W and Q16W

The study has 2 parts: Original Design Cohorts (ODC) and New Design Cohorts. (NDH) Participants in the two parts' cohorts are separate and sequential.

Participant milestones

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC RO7234292 120 mg Q4W	RO7234292 Q8W ODC RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC NDC Arms were enrolled after the completion of ODC	Placebo NDC NDC Arms were enrolled after the completion of ODC
Overall Study STARTED	36	36	36	263	264	264
Overall Study COMPLETED	0	0	0	216	207	211
Overall Study NOT COMPLETED	36	36	36	47	57	53

Reasons for withdrawal

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC RO7234292 120 mg Q4W	RO7234292 Q8W ODC RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC NDC Arms were enrolled after the completion of ODC	Placebo NDC NDC Arms were enrolled after the completion of ODC
Overall Study transferred to OpenLabelExtension	35	34	36	0	0	0
Overall Study Adverse Event	1	0	0	0	2	3
Overall Study Withdrawal by Subject	0	0	0	41	43	35
Overall Study Lost to Follow-up	0	1	0	2	4	5
Overall Study Repeated MRI dId not pass QC.	0	1	0	0	0	0
Overall Study Physician Decision	0	0	0	1	4	4
Overall Study Death	0	0	0	1	1	3
Overall Study Protocol Violation	0	0	0	2	2	1
Overall Study Participant could not come to site	0	0	0	0	1	0
Overall Study SF- safety Finding	0	0	0	0	0	1
Overall Study Patient did not attend visit	0	0	0	0	0	1

Baseline Characteristics

Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled

Baseline characteristics by cohort

Measure	Placebo ODC n=36 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=35 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=36 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Total n=888 Participants Total of all reporting groups
Age, Continuous	45.2 Years STANDARD_DEVIATION 11.0 • n=36 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	44.9 Years STANDARD_DEVIATION 9.8 • n=35 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	47.7 Years STANDARD_DEVIATION 9.7 • n=36 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	47.8 Years STANDARD_DEVIATION 9.6 • n=260 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	47.5 Years STANDARD_DEVIATION 9.3 • n=261 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	48.7 Years STANDARD_DEVIATION 9.9 • n=260 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	47.8 Years STANDARD_DEVIATION 9.7 • n=888 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled
Sex: Female, Male Female	22 Participants n=36 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	16 Participants n=35 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	23 Participants n=36 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	111 Participants n=260 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	128 Participants n=261 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	113 Participants n=260 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	413 Participants n=888 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled
Race (NIH/OMB) Asian	1 Participants n=36 Participants	0 Participants n=35 Participants	0 Participants n=36 Participants	5 Participants n=260 Participants	4 Participants n=261 Participants	3 Participants n=260 Participants	13 Participants n=888 Participants
Sex: Female, Male Male	14 Participants n=36 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	19 Participants n=35 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	13 Participants n=36 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	149 Participants n=260 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	133 Participants n=261 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	147 Participants n=260 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled	475 Participants n=888 Participants • Not all participants were dosed. ODC and NDC are not mutually exclusive arms. First ODC participants completed the milestone and afterwards, different NDC participants were enrolled
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=36 Participants • Evaluable participants data are included	3 Participants n=35 Participants • Evaluable participants data are included	7 Participants n=36 Participants • Evaluable participants data are included	34 Participants n=260 Participants • Evaluable participants data are included	38 Participants n=261 Participants • Evaluable participants data are included	30 Participants n=259 Participants • Evaluable participants data are included	120 Participants n=887 Participants • Evaluable participants data are included
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=36 Participants • Evaluable participants data are included	32 Participants n=35 Participants • Evaluable participants data are included	29 Participants n=36 Participants • Evaluable participants data are included	222 Participants n=260 Participants • Evaluable participants data are included	215 Participants n=261 Participants • Evaluable participants data are included	222 Participants n=259 Participants • Evaluable participants data are included	748 Participants n=887 Participants • Evaluable participants data are included
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=36 Participants • Evaluable participants data are included	0 Participants n=35 Participants • Evaluable participants data are included	0 Participants n=36 Participants • Evaluable participants data are included	4 Participants n=260 Participants • Evaluable participants data are included	8 Participants n=261 Participants • Evaluable participants data are included	7 Participants n=259 Participants • Evaluable participants data are included	19 Participants n=887 Participants • Evaluable participants data are included
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=36 Participants	0 Participants n=35 Participants	0 Participants n=36 Participants	1 Participants n=260 Participants	2 Participants n=261 Participants	0 Participants n=260 Participants	3 Participants n=888 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=36 Participants	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=260 Participants	0 Participants n=261 Participants	0 Participants n=260 Participants	0 Participants n=888 Participants
Race (NIH/OMB) Black or African American	1 Participants n=36 Participants	0 Participants n=35 Participants	0 Participants n=36 Participants	1 Participants n=260 Participants	1 Participants n=261 Participants	0 Participants n=260 Participants	3 Participants n=888 Participants
Race (NIH/OMB) White	33 Participants n=36 Participants	35 Participants n=35 Participants	36 Participants n=36 Participants	246 Participants n=260 Participants	245 Participants n=261 Participants	246 Participants n=260 Participants	841 Participants n=888 Participants
Race (NIH/OMB) More than one race	1 Participants n=36 Participants	0 Participants n=35 Participants	0 Participants n=36 Participants	0 Participants n=260 Participants	1 Participants n=261 Participants	0 Participants n=260 Participants	2 Participants n=888 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=36 Participants	0 Participants n=35 Participants	0 Participants n=36 Participants	7 Participants n=260 Participants	8 Participants n=261 Participants	11 Participants n=260 Participants	26 Participants n=888 Participants

PRIMARY outcome

Timeframe: Weeks 21 for ODC and 69 for NDC

Population: ITT Population. Only those participants who contributed to data reported in the table. All other data were not evaluable.

cUHDRS includes the Total Functional Capacity (range, 0-13; higher score means better functioning), Total Motor Score (range, 0-124; higher score means worse motor severity), Symbol Digit Modality Test (range, 0-110, correctly paired numbers-symbols in 90 seconds; higher score means better cognitive performance), and Stroop Word Reading (range, 0-no max value, correctly read colour words in 45 seconds; higher score means better cognitive performance) scores. A z-score for each test is calculated, which alone can be used to describe relationship between an individual's test score and the mean score of a target population. A z-score of 0 is the mean, and ±1 is 1 standard deviation from the mean. For cUHDRS, z-scores of each test are summed, whereby a higher cUHDRS score is better (score of -3.06-no max value) and a change of ≥1.2 is a meaningful worsening, shown to track functional decline.

Outcome measures

Measure	Placebo ODC n=28 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=29 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=25 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS) Score-Z Score Week 21	0.103 Scores on a Scale Standard Error 0.193	-0.367 Scores on a Scale Standard Error 0.189	-0.139 Scores on a Scale Standard Error 0.197	—	—	—
Change From Baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS) Score-Z Score Week 69	—	—	—	-1.173 Scores on a Scale Standard Error 0.091	-0.793 Scores on a Scale Standard Error 0.093	-0.630 Scores on a Scale Standard Error 0.091

PRIMARY outcome

Timeframe: Weeks 21 for ODC and 69 for NDC

Population: ITT Population. Only those participants who contributed to data reported in the table. All other data were not evaluable.

Total Functional Capacity (TFC) Scores are reported at Weeks 21 and 69. Total Functional Capacity Score ranges from 0 to 13, with a higher score representing better functioning.

Outcome measures

Measure	Placebo ODC n=29 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=30 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=25 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=203 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=199 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=206 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in the Total Functional Capacity (TFC) Score Week 21	0.150 Scores on a Scale Standard Error 0.246	-0.463 Scores on a Scale Standard Error 0.242	-0.460 Scores on a Scale Standard Error 0.255	—	—	—
Change From Baseline in the Total Functional Capacity (TFC) Score Week 69	—	—	—	-1.284 Scores on a Scale Standard Error 0.124	-0.921 Scores on a Scale Standard Error 0.126	-0.883 Scores on a Scale Standard Error 0.124

SECONDARY outcome

Timeframe: Weeks 21 for ODC and 69 for NDC

Population: ITT Population. Only those participants who contributed to data reported in the table. All other data were not evaluable.

The TMS score is the sum of the individual motor ratings obtained from administration of the 31-item motor assessment. The score ranges from 0 to 124, with a higher score representing more severe impairment.

Outcome measures

Measure	Placebo ODC n=29 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=30 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=25 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=200 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=193 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=203 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in Total Motor Score (TMS) Week 21	-1.977 Score on a Scale Standard Error 1.407	2.570 Score on a Scale Standard Error 0.542	1.493 Score on a Scale Standard Error 0.78	—	—	—
Change From Baseline in Total Motor Score (TMS) Week 69	—	—	—	4.028 Score on a Scale Standard Error 0.575	3.524 Score on a Scale Standard Error 0.583	3.513 Score on a Scale Standard Error 0.573

SECONDARY outcome

Timeframe: Weeks 21 for ODC and 69 NDC

Population: ITT Population. Only those participants who contributed to data reported in the table. All other data were not evaluable.

Symbol Digit Modality Test -SDMT test measures the number of items correctly paired maximum of 110 correct pairs in 90 seconds, more correctly paired items representing less impairment.

The differences in LS mean ( +/-SE) change from baseline SDMT score between the active groups compared with the placebo group at Weeks 21 and 69 were reported. A negative change from baseline in the SDMT indicates disease progression.

The Least Square Mean values of Symbol Digit Modality Test Scores are reported below.

The minimum range for the SDMT scale is 0, indicating highest severity. A max number is not possible as it is a time based task, based on the number of correct answers within a set time frame. There are no validated SDMT score thresholds to indicate the level of HD symptom severity.

Outcome measures

Measure	Placebo ODC n=28 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=29 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=27 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=200 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=193 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=202 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in Symbol Digit Modalities Test (SDMT) Scores' Least Squares Mean Values Week 21	1.865 Scores on a scale Standard Error 0.886	-1.166 Scores on a scale Standard Error 0.867	1.204 Scores on a scale Standard Error 0.879	—	—	—
Change From Baseline in Symbol Digit Modalities Test (SDMT) Scores' Least Squares Mean Values Week 69	—	—	—	-2.641 Scores on a scale Standard Error 0.380	-0.996 Scores on a scale Standard Error 0.385	-0.216 Scores on a scale Standard Error 0.379

SECONDARY outcome

Timeframe: Weeks 21 for ODC and 69 for NDC

Population: ITT Population. Only those participants who contributed to data reported in the table. All other data were not evaluable.

Stroop Word Reading-SWR number of words and colors read correctly is counted, with a higher score indicating better cognitive performance scores. There is no upper limit for SWR as it is a time based task. The lower limit (worst possible) however is 0; higher score is better meaning less severity.

The differences in LS mean ( +/-SE) change from baseline SWR score between the active groups compared with the placebo group at Weeks 21 and 69 were reported. A negative change from baseline in the SWR indicates disease progression.

The Least Square Mean values of Stroop Word Reading (SWR) Test Scores are reported below.

Outcome measures

Measure	Placebo ODC n=28 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=29 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=27 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=200 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=193 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=202 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in Stroop Word Reading (SWR) Test Scores' Least Squares Mean Values Week 21	-1.397 Scores on a Scale Standard Error 1.902	0.469 Scores on a Scale Standard Error 1.847	-1.036 Scores on a Scale Standard Error 1.842	—	—	—
Change From Baseline in Stroop Word Reading (SWR) Test Scores' Least Squares Mean Values Week 69	—	—	—	-5.224 Scores on a Scale Standard Error 0.803	-3.949 Scores on a Scale Standard Error 0.815	-2.555 Scores on a Scale Standard Error 0.802

SECONDARY outcome

Timeframe: Week 69 for NDC Only

Population: ITT Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. No data could be reported in ODC Arms due to no data were collected.

The CGI-S is a single-item measure of current global severity and is completed by the clinician at specified clinic visits. The CGI-S is assessed using an 11-point numeric rating scale (NRS), where higher scores indicate greater severity. Only NDC participants data were reported, all other data were not available.

CGI-S) Scores range from 0 (not at all severe) to 10 (Extremely severe); lower score is better meaning less severity.

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC RO7234292 120 mg Q4W	RO7234292 Q8W ODC RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=200 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=197 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=203 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in the Clinical Global Impression, Severity Scale (CGI-S) Scores' Least Squares Mean Values	—	—	—	0.662 Scores on a Scale Standard Error 0.093	0.640 Scores on a Scale Standard Error 0.094	0.545 Scores on a Scale Standard Error 0.093

SECONDARY outcome

Timeframe: Week 69 for NDC only

Population: ITT Population. Only those participants who contributed to data reported in the table. All other data were not evaluable. No data could be reported in ODC Arms due to no data were collected.

Only NDC participant data are available and reported. Total Functional Capacity-TFC score ranges from 0 to 13, with a higher score representing better functioning.

In this outcome measure, participants with 1 or higher point score decrease from the Baseline TFC Total Score was considered. The Percentage of these participants with such a change was calculated.

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC RO7234292 120 mg Q4W	RO7234292 Q8W ODC RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Percentage of Patients With a Decrease From Baseline of >=1 Point on the Total Functional Capacity (TFC) Score Week 69 Decline from baseline at least 1.2 points No	—	—	—	44.3 Percentage	49.7 Percentage	43.7 Percentage
Percentage of Patients With a Decrease From Baseline of >=1 Point on the Total Functional Capacity (TFC) Score Week 69 Decline from baseline at least 1.2 points Yes	—	—	—	55.7 Percentage	50.3 Percentage	49.5 Percentage

SECONDARY outcome

Timeframe: Week 69 for NDC Only

Population: ITT Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. No data could be reported in ODC Arms due to no data were collected.

Only NDC participant data are available and reported. The cUHDRS is comprised of the sum scores of the subscales, score ranges and severities mentioned in the Outcome Measure Description 1 (please see above).

In this outcome measure, participants with 1.2 or higher point score decrease from the Baseline Composite Unified Huntington's Disease Rating Scale- cUHDRS Total Score was considered. The Percentage of these participants with such a change was calculated.

cUHDRS lowest (worst) score possible value is -3.06 but no upper limit as it involves SWR; higher score is better meaning less severity.

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC RO7234292 120 mg Q4W	RO7234292 Q8W ODC RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Percentage of Patients With a Decline From Baseline of >=1.2 Points on the Composite Unified Huntington's Disease Rating Scale-cUHDRS Score Week 69 Yes	—	—	—	44.5 Percentage of Participants	32.1 Percentage of Participants	29.7 Percentage of Participants
Percentage of Patients With a Decline From Baseline of >=1.2 Points on the Composite Unified Huntington's Disease Rating Scale-cUHDRS Score Week 69 No	—	—	—	55.5 Percentage of Participants	67.9 Percentage of Participants	70.3 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 53 and 69 NDC only

Population: ITT Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. No data could be reported in ODC Arms due to no data were collected.

The Clinical Global Impression, Change - CGI-C Scale is a single-item measure of change in global status scale and total scores are summed and reported. The CGI-C has 7 response options: "very much worse," "much worse," "minimally worse," "no change," "minimally improved," "much improved," and "very much improved." "Yes", "No" responses collected and total scores are summed and reported below. Percentage of participants who have unchanged or improved scores from the Baseline CGI-C Scores are calculated and reported here.

Total CGI-C scores range from 1 (Very much improved) to 7 (Very much worse); lower score is better meaning less severity. Only NDC Arms data were available. Minimum and maximum values are 1 and 7 respectively.

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC RO7234292 120 mg Q4W	RO7234292 Q8W ODC RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Percentage of Patients With an Unchanged or Improved Score on the Clinical Global Impression, Change Scale Score Week 69 Yes	—	—	—	55.4 Percentage of Participants	59.6 Percentage of Participants	56.3 Percentage of Participants
Percentage of Patients With an Unchanged or Improved Score on the Clinical Global Impression, Change Scale Score Week 69 No	—	—	—	44.6 Percentage of Participants	40.4 Percentage of Participants	43.7 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 117 Weeks (29 months)

Population: Safety Population

Outcome measures

Measure	Placebo ODC n=36 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=35 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=36 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Percentage of Participants With Adverse Events	77.8 Percentage	80.0 Percentage	61.1 Percentage	92.3 Percentage	90.0 Percentage	93.1 Percentage

SECONDARY outcome

Timeframe: Up to Week 21 for ODC, Up to Week 69 for NDC

Population: ITT Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. NDC participants number are different at Week 21 and 69, reported data are from all evaluable participants.

ODC Week 21 and NDC Week 69 data were reportable. Total MOCA scores are reported. The MoCA is a patient-completed assessment used to detect cognitive impairment. It contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment.

Outcome measures

Measure	Placebo ODC n=28 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=29 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=27 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=250 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=246 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=256 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in Montreal Cognitive Assessment (MoCA) Week 21	-0.07 Scores on a Sclae Standard Deviation 0.86	0.10 Scores on a Sclae Standard Deviation 1.37	0.33 Scores on a Sclae Standard Deviation 0.92	0.44 Scores on a Sclae Standard Deviation 2.91	0.39 Scores on a Sclae Standard Deviation 2.66	0.45 Scores on a Sclae Standard Deviation 2.29
Change From Baseline in Montreal Cognitive Assessment (MoCA) Week 69	—	—	—	0.15 Scores on a Sclae Standard Deviation 3.26	0.43 Scores on a Sclae Standard Deviation 3.22	0.61 Scores on a Sclae Standard Deviation 2.44

SECONDARY outcome

Timeframe: For ODC at 13th Month, for NDC at Week 101

Population: Safety Population

SI-Suicidal Idealation. For ODC, only Treatment Emergent Suicide-Related Events Based on the Columbia-Suicide Severity Rating Scale (CSSRS) are reported. Four constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety (Posner et al. 2011). It maps to the Columbia-Classification Algorithm for Suicide Assessment and meets the criteria listed in the U.S. FDA draft guidance for assessment of suicidality in clinical trials (FDA 2012). The higher scores indicate higher severity

Outcome measures

Measure	Placebo ODC n=35 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=35 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=35 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=259 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=260 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Ideation (1-5) 1) Wish to Be Dead	0 Percentage	8.6 Percentage	2.8 Percentage	9.7 Percentage	11.2 Percentage	10.4 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Ideation (1-5) 2) Non-specific Active Suicidal Thoughts	0 Percentage	8.6 Percentage	2.8 Percentage	6.9 Percentage	5.8 Percentage	5.8 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score SI(1-5) 3) Active Suicidal Ideation with Methods (Not Plan) without Intent to Act	0 Percentage	2.9 Percentage	0 Percentage	3.5 Percentage	3.5 Percentage	4.2 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Ideation (1-5) 4) Active Suicidal Ideation with Some Intent to Act, without Specific Plan	0 Percentage	0 Percentage	0 Percentage	2.3 Percentage	0.4 Percentage	1.2 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Ideation (1-5) 5) Active Suicidal Ideation with Specific Plan and Intent	0 Percentage	0 Percentage	0 Percentage	1.9 Percentage	0 Percentage	1.2 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Behavior (6-10) 6) Preparatory Acts or Behavior	0 Percentage	0 Percentage	0 Percentage	0.8 Percentage	0.8 Percentage	0.8 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Behavior (6-10) 7) Aborted Attempt	0 Percentage	0 Percentage	0 Percentage	0.4 Percentage	0.4 Percentage	0.4 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Behavior (6-10)8)Interrupted Attempt	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0.4 Percentage	0.4 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Behavior (6-10) 9) Non-fatal Suicide Attempt	0 Percentage	0 Percentage	0 Percentage	1.5 Percentage	1.5 Percentage	1.5 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Behavior (6-10) 10) Completed Suicide	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage	0 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Self-injurious Behavior without Suicidal Intent	0 Percentage	0 Percentage	0 Percentage	0.4 Percentage	1.2 Percentage	1.2 Percentage
Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score Suicidal Ideation or Behavior1-5)	0 Percentage	8.6 Percentage	2.8 Percentage	10.0 Percentage	11.2 Percentage	10.8 Percentage

SECONDARY outcome

Timeframe: Week 21 for ODC and Week 69 for NDC

Population: Pharmacokinetic Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. NDC participants number are different at Week 21 and 69, reported data are from all evaluable participants.

Concentration of tominersen in plasma reported

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC n=35 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=36 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=250 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=243 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC NDC Arms were enrolled after the completion of ODC
Concentration of RO7234292 in Plasma Week 21 Pre--dose	—	0.511 ng/mL Standard Deviation 0.523	0.203 ng/mL Standard Deviation 0.0948	0.20 ng/mL Standard Deviation 0.37	0.06 ng/mL Standard Deviation 0.22	—
Concentration of RO7234292 in Plasma Week 69 Pre dose	—	—	—	1.63 ng/mL Standard Deviation 3.40	0.28 ng/mL Standard Deviation 0.75	—

SECONDARY outcome

Timeframe: Week 21 for ODC and Week 69 for NDC

Population: Pharmacokinetic Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. NDC participants number are different at Week 21 and 69, reported data are from all evaluable participants.

Tominersen concentrations in cerebrospinal fluid

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC n=35 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=36 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=189 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=182 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC NDC Arms were enrolled after the completion of ODC
Trough Concentration of RO7234292 in Cerebrospinal Fluid (CSF) Week 21	—	4.44 ng/mL Standard Error 2.24	1.51 ng/mL Standard Error 0.604	1.54 ng/mL Standard Error 0.99	0.70 ng/mL Standard Error 2.29	—
Trough Concentration of RO7234292 in Cerebrospinal Fluid (CSF) Week 69	—	—	—	1.74 ng/mL Standard Error 1.08	0.55 ng/mL Standard Error 2.43	—

SECONDARY outcome

Timeframe: Week 21 for ODC and Week 69 for NDC

Population: Pharmacokinetic Population. Only those participants who were contributed data reported in the table. All other data were not evaluable.

Data at Weeks 21 and 69 for Old Design and New Design Cohorts are reported respectively. All other timepoints were not evaluable and not meaningful.

Outcome measures

Measure	Placebo ODC Matching Placebo Q4W	RO7234292 Q4W ODC n=29 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=27 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=190 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=261 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=260 Participants NDC Arms were enrolled after the completion of ODC
Incidence of Anti-Drug Antibodies (ADAs). Week 69 Total Positive	—	—	—	28.9 Percentage	18.3 Percentage	22.0 Percentage
Incidence of Anti-Drug Antibodies (ADAs). Week 21 Total Negative	—	94.3 Percentage	91.7 Percentage	—	—	—
Incidence of Anti-Drug Antibodies (ADAs). Week 21 Negative Treatment All Samples	—	91.4 Percentage	91.7 Percentage	—	—	—
Incidence of Anti-Drug Antibodies (ADAs). Week 21 Total Positive Treatment unaffected	—	2.9 Percentage	0 Percentage	—	—	—
Incidence of Anti-Drug Antibodies (ADAs). Week 69 Total Negative	—	—	—	71.1 Percentage	81.7 Percentage	100 Percentage
Incidence of Anti-Drug Antibodies (ADAs). Week 69 Negative Treatment Unaffected	—	—	—	0 Percentage	1.1 Percentage	0.5 Percentage
Incidence of Anti-Drug Antibodies (ADAs). Week 69 Positive Treatment Induced	—	—	—	0 Percentage	0 Percentage	0 Percentage

SECONDARY outcome

Timeframe: Week 21 for ODC and Week 69 for NDC

Population: No participants and no data to report

Titer and Antibody Subtype was not analyzed and there is not data to report due to participants' discontinuation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 101

Data to be reported within 12 months after the primary completion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 13 for ODC

Population: Pharmacokinetic Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. No data could be reported in NDC Arm Week due to no data were collected, no participants were involved in this Arm.

Data reported only for ODC Arms. Analysis of Percent Change from Baseline in Volumetric MRI / BSI at 3 Months reported. Analysis performed using analysis of covariance with covariates of CAP, CAG, Age at Baseline and treatment included.

Analysis of Change from Baseline in: Caudate Volume (mL)

Outcome measures

Measure	Placebo ODC n=34 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=31 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=32 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC NDC Arms were enrolled after the completion of ODC	Placebo NDC NDC Arms were enrolled after the completion of ODC
Change From Baseline in Whole and Regional Brain Volumes, as Detrmined by Structural Magnetic Resonance Imaging (MRI) Week 13 Analysis of Change from Baseline in: Caudate Volume (mL)	0.996 mL Standard Error 0.444	0.330 mL Standard Error 0.491	1.124 mL Standard Error 0.467	—	—	—
Change From Baseline in Whole and Regional Brain Volumes, as Detrmined by Structural Magnetic Resonance Imaging (MRI) Week 13 Change from Baseline in: Ventricle Volume (mL)	1.537 mL Standard Error 0.686	3.785 mL Standard Error 0.718	2.011 mL Standard Error 0.700	—	—	—
Change From Baseline in Whole and Regional Brain Volumes, as Detrmined by Structural Magnetic Resonance Imaging (MRI) Week 13 Change from Baseline in: Whole Brain Volume (mL)	0.189 mL Standard Error 0.119	-0.184 mL Standard Error 0.123	-0.133 mL Standard Error 0.121	—	—	—

SECONDARY outcome

Timeframe: Week 21 for ODC, Weeks 21 and 69 for NDC

Population: ITT Population. Only those participants who were contributed data reported in the table. All other data were not evaluable. No data could be reported in ODC Arm Week 69 due to no data were collected.

Outcome measures

Measure	Placebo ODC n=28 Participants Matching Placebo Q4W	RO7234292 Q4W ODC n=28 Participants RO7234292 120 mg Q4W	RO7234292 Q8W ODC n=27 Participants RO7234292 120 mg Q8W	Tomi 120 mg Q8W NDC n=224 Participants NDC Arms were enrolled after the completion of ODC	Tomi 120mg Q16W NDC n=209 Participants NDC Arms were enrolled after the completion of ODC	Placebo NDC n=225 Participants NDC Arms were enrolled after the completion of ODC
Change From Baseline in CSF Neurofilament Light Chain (NfL) Proteint Level Week 21	12.233 ng/mL Interval 0.729 to 25.05	34.548 ng/mL Interval 20.671 to 50.022	16.553 ng/mL Interval 4.497 to 29.999	31.893 ng/mL Interval 24.946 to 39.226	5.406 ng/mL Interval -0.335 to 11.479	3.365 ng/mL Interval -2.077 to 9.109
Change From Baseline in CSF Neurofilament Light Chain (NfL) Proteint Level Week 69	—	—	—	9.996 ng/mL Interval 3.538 to 16.858	-2.559 ng/mL Interval -8.439 to 3.699	5.982 ng/mL Interval -0.293 to 12.652

Adverse Events

PLB ODC

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

Q4W ODC

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Q8W ODC

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Q8W NDC

Serious events: 50 serious events

Other events: 204 other events

Deaths: 1 deaths

Q16W NDC

Serious events: 28 serious events

Other events: 187 other events

Deaths: 2 deaths

PLB NDC

Serious events: 34 serious events

Other events: 193 other events

Deaths: 3 deaths

Serious adverse events

Measure	PLB ODC n=36 participants at risk Placebo Q4W every 16 Week	Q4W ODC n=36 participants at risk RO7234292 loading dose: 120 mg at every 16 Week	Q8W ODC n=36 participants at risk RO7234292: 120 mg Q8W from Week 1 to Week 69	Q8W NDC n=263 participants at risk NDC Arms were enrolled after the completion of ODC	Q16W NDC n=264 participants at risk NDC Arms were enrolled after the completion of ODC	PLB NDC n=264 participants at risk NDC Arms were enrolled after the completion of ODC
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Cardiac disorders Atrial fibrillation	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Cardiac disorders Myocardial infarction	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Ear and labyrinth disorders Vertigo positional	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Constipation	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Ileus	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Intestinal perforation	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Nausea	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Volvulus	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Asthenia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Death	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Gait disturbance	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Ill-defined disorder	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Pain	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Pyrexia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Immune system disorders Anaphylactic reaction	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Anal abscess	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations COVID-19	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations COVID-19 pneumonia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Gastroenteritis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Meningitis aseptic	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Peritonitis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Pneumonia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Respiratory tract infection	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Septic shock	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Subcutaneous abscess	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Urinary tract infection	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Viral infection	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Comminuted fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Concussion	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Fall	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Femur fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Hip fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Injury	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Post lumbar puncture syndrome	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.1% 3/263 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Procedural headache	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Rib fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Skin laceration	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Stab wound	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.5% 4/263 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Wound haematoma	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Investigations Bacterial test positive	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Investigations Hepatic enzyme increased	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Metabolism and nutrition disorders Water intoxication	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Ataxia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Cerebral ischaemia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Chorea	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Demyelination	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Depressed level of consciousness	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Dyskinesia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Dystonia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Haemorrhage intracranial	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Headache	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Hydrocephalus	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Intracranial hypotension	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Paraesthesia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Post herpetic neuralgia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Presyncope	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Psychomotor hyperactivity	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Seizure	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Transient ischaemic attack	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Aggression	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Agitation	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Alcohol abuse	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Alcoholism	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Anxiety	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Assisted suicide	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Completed suicide	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Delirium	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Delusion	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Delusion of parasitosis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Depressed mood	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Depression	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Depression suicidal	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Hallucination, auditory	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Hallucination, tactile	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Impulse-control disorder	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Major depression	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Mania	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Mood altered	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Panic attack	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Persecutory delusion	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Psychotic disorder	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Suicidal ideation	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Suicide attempt	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.3% 6/263 • Number of events 7 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.1% 3/264 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Reproductive system and breast disorders Prostatitis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Vascular disorders Aortic aneurysm	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Vascular disorders Deep vein thrombosis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Vascular disorders Subclavian artery thrombosis	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks

Other adverse events

Measure	PLB ODC n=36 participants at risk Placebo Q4W every 16 Week	Q4W ODC n=36 participants at risk RO7234292 loading dose: 120 mg at every 16 Week	Q8W ODC n=36 participants at risk RO7234292: 120 mg Q8W from Week 1 to Week 69	Q8W NDC n=263 participants at risk NDC Arms were enrolled after the completion of ODC	Q16W NDC n=264 participants at risk NDC Arms were enrolled after the completion of ODC	PLB NDC n=264 participants at risk NDC Arms were enrolled after the completion of ODC
Gastrointestinal disorders Diarrhoea	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.5% 17/263 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.7% 15/264 • Number of events 16 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	7.2% 19/264 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Nausea	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.6% 12/263 • Number of events 14 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.5% 12/264 • Number of events 17 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.7% 15/264 • Number of events 19 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Gastrointestinal disorders Vomiting	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.3% 14/263 • Number of events 17 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.1% 16/264 • Number of events 22 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.1% 16/264 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Fatigue	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.8% 10/263 • Number of events 13 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.4% 17/264 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.8% 10/264 • Number of events 10 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Gait disturbance	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	11.1% 4/36 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.8% 10/263 • Number of events 11 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.1% 3/264 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Puncture site pain	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	9.1% 24/263 • Number of events 45 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.9% 13/264 • Number of events 17 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	9.1% 24/264 • Number of events 46 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
General disorders Pyrexia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.6% 12/263 • Number of events 13 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.3% 14/264 • Number of events 17 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.9% 13/264 • Number of events 16 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Fungal infection	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/263 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Nasopharyngitis	8.3% 3/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	13.7% 36/263 • Number of events 48 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	10.6% 28/264 • Number of events 40 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	16.7% 44/264 • Number of events 61 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Infections and infestations Urinary tract infection	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	11.1% 4/36 • Number of events 5 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.9% 13/263 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.9% 13/264 • Number of events 14 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.0% 8/264 • Number of events 18 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Contusion	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.1% 16/263 • Number of events 19 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.7% 15/264 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.8% 18/264 • Number of events 30 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Fall	11.1% 4/36 • Number of events 6 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	11.1% 4/36 • Number of events 6 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	26.6% 70/263 • Number of events 136 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	23.9% 63/264 • Number of events 141 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	29.9% 79/264 • Number of events 170 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Inappropriate schedule of product administration	8.3% 3/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Post lumbar puncture syndrome	11.1% 4/36 • Number of events 6 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.3% 3/36 • Number of events 6 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	19.4% 7/36 • Number of events 8 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	9.1% 24/263 • Number of events 34 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.8% 18/264 • Number of events 28 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.0% 21/264 • Number of events 39 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Procedural pain	11.1% 4/36 • Number of events 8 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	16.7% 6/36 • Number of events 11 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	13.9% 5/36 • Number of events 9 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.7% 23/263 • Number of events 51 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.0% 21/264 • Number of events 31 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.3% 22/264 • Number of events 29 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Investigations CSF protein increased	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.3% 3/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.9% 13/263 • Number of events 13 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.38% 1/264 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/264 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	7.2% 19/263 • Number of events 22 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.5% 12/264 • Number of events 13 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.3% 22/264 • Number of events 32 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Back pain	11.1% 4/36 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	11.1% 4/36 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	21.7% 57/263 • Number of events 91 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	22.0% 58/264 • Number of events 93 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	18.6% 49/264 • Number of events 92 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Musculoskeletal and connective tissue disorders Pain in extremity	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	7.2% 19/263 • Number of events 30 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.3% 14/264 • Number of events 16 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.7% 15/264 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Dizziness	8.3% 3/36 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	7.6% 20/263 • Number of events 33 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.3% 22/264 • Number of events 31 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.4% 17/264 • Number of events 19 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Headache	16.7% 6/36 • Number of events 9 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	8.3% 3/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	11.1% 4/36 • Number of events 6 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	23.2% 61/263 • Number of events 150 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	21.6% 57/264 • Number of events 105 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	22.3% 59/264 • Number of events 114 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Paraesthesia	8.3% 3/36 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.7% 7/263 • Number of events 10 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.0% 8/264 • Number of events 10 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.3% 6/264 • Number of events 10 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Somnolence	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.8% 10/263 • Number of events 15 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.5% 4/264 • Number of events 4 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.9% 5/264 • Number of events 5 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Anxiety	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	6.1% 16/263 • Number of events 20 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.2% 11/264 • Number of events 12 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.7% 15/264 • Number of events 16 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Psychiatric disorders Insomnia	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	2.8% 1/36 • Number of events 1 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.2% 11/263 • Number of events 14 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.7% 15/264 • Number of events 16 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.9% 13/264 • Number of events 16 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Injury, poisoning and procedural complications Skin laceration	5.6% 2/36 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	4.6% 12/263 • Number of events 14 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.9% 5/264 • Number of events 5 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	3.0% 8/264 • Number of events 11 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Nervous system disorders Tremor	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.76% 2/263 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/264 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks
Vascular disorders Haematoma	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	0.00% 0/36 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	5.6% 2/36 • Number of events 2 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.1% 3/263 • Number of events 3 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.1% 3/264 • Number of events 5 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks	1.1% 3/264 • Number of events 5 • For ODC Up to 13 Months. For NDC Approximately Up to 137 Weeks

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

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